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Study Title Principal Investigator
A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma
This is an open label, multi-center, single arm phase II study. The study will investigate the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of patients with recurrent or persistent PrR-negative endometrial cancer. Eligible patients will be enrolled into the study and administered sodium cridanimod in combination progestin therapy. Objective responses will be assessed at 12 week intervals. Patients will be treated for a 12 month period, followed by an additional 12 month follow up period or to disease progression whichever occurs first. Important objectives of the study are to investigate the effect of sodium cridanimod in conjunction with progestin therapy on the level of PrR in tumor tissue and how this correlates to efficacy. To accomplish this objective, some of the patients enrolled in the study will undergo two tumor biopsies that will allow measurement of PrR levels in the tumor tissue before the treatment and after 4 weeks of therapy.
Recruiting | Gynecologic Cancers | Multisite
Lynda Roman
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GOG-0225 CAN DIET AND PHYSICAL ACTIVITY MODULATE OVARIAN, FALLOPIAN TUBE AND PRIMARY PERITONEAL CANCER PROGRESSION-FREE SURVIVAL?
Ovarian cancer is diagnosed in approximately 22,430 women annually in the United States. The Gynecological Oncology Group affords a unique opportunity to test hypotheses relating dietary intake and increased physical activity to improved progression-free survival among women diagnosed with ovarian cancer.The lifestyle intervention, which consist of 20% total energy as dietary fat, greater than 6 colorful vegetables and fruit servings, plus 4,000+ additional steps daily, included in this protocol is consistent with national and international recommendations for cancer prevention and survival.Primay Objective:To determine if women who are disease-free after successfully completing primary and potential consolidation/maintenance, therapy for Stage II-IV ovarian, fallopian tube or primary peritoneal cancer and who are randomized to a healthy lifestyle intervention will have significantly increased progressionfree survival compared to similar women who are randomized to a usual carecomparison group.Study Population:Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis.Study Arms:Women will be randomized 1:1 to intervention versus control and randomization will include stratification according to consolidation therapy (yes/no) as well as stage at diagnosis (II, III, or IV)Endpoints:Patients experiencing a recurrence of disease or a second primary cancer event will have reached the targeted study endpoint.Follow up:follow-up will be at 3 month intervals for the first 2 years, 6 month intervals for the next 3 years, and annually thereafter.Analysis:The overall effectiveness of the intervention will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no). Progression-free survival time for those who are still alive and have not been observed to fail by study end will be treated as censored observations.
Recruiting | Stomach Cancer | Multisite
Huyen Pham
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5C-11-2 Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
Cervical cancer is the second most common cancer in women worldwide; and, in developing countries, it is the leading cause of death by cancer. Treatment for advanced disease after the use of platinum based therapy yields low response and survival rates, therefore there is a huge need for the identification of active agents.. Eribulin is a targeted agent that inhibits cell growth in multiple types of cancers. Previous studies have shown that it improves response and survival rates. This study is a phase II, single arm, two-stage study using eribulin in patients with advanced cervical cancer. The primary objective of this study is to evaluate the effectiveness of eribulin in these patients.Patients with laboratory confirmed invasive cervical cancer who have had up to 1 previous chemotherapy regimen for advanced disease will be considered for this study. Once patients have agreed to participate, they will be screened for eligibility. Once they are deemed eligible, they will receive eribulin through a vein in the arm on Days 1 and 8 of a 21-day treatment cycle. They will have a study visits during each cycle that will include the following tests and procedures: blood tests, physical exams, vital signs, ECG to check their heart, evaluation of their ability to carry out everyday activities, and an evaluation of side effects. They will also have x-rays or CT/MRI scans to determine whether their tumor is growing. Tumor tissue from a previous biopsy or surgery and blood samples will be collected for research testing. Subjects will continue taking the study drug until their tumor grows or they have unacceptable side effects.Fifteeen patients will be treated and evaluated in the first stage; if 1 or more of the 15 patients achieves a progression free survival of 6 months, an additional 15 patients will be accrued into the second stage.The primary efficacy endpoint will be 6-month progression-free survival. The secondary efficacy endpoint will be best overall response. The occurrence of toxic death (TD) at any time will be a primary endpoint for safety monitoring. The study will be terminated if fewer than 1 out of 15 patients are progression-free at 6 months.
Recruiting | Gynecologic Cancers | Not Multisite
Lynda Roman
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0C-14-10: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies
This is a phase I, open-label, multicentre study of AZD5363 administered orally in participants with advanced solid malignancies. AZD5363 is a novel, potent, selective inhibitor of the kinase activity of AKT (also known as protein kinase B). AZD5363 acts on cancers by blocking signalling through the AKT cellular survival pathway, leading to inhibition of cell proliferation and increased cell death. There are 6 parts to this study. USC will only take part in parts C, D, E and F. Parts C, D, E and F will investigate the tolerability and initial signs of anti-tumour activity of AZD5363 in tumour types that are considered most likely to be sensitive to AKT inhibition, as a result of bearing a mutation of PIK3CA, AKT1, PTEN or other molecular aberrations leading to dysregulation of the PI3K/AKT pathway. Part C will focus on tumours with a mutation of PIK3CA and will contain three separate cohorts Part D will focus on tumours with mutations of AKT1 or other molecular aberrations leading to dysregulation of the PI3K/AKT pathway, and will contain three separate cohorts Part E will focus on patients with advanced or metastatic ER positive breast tumours with mutations of AKT1 and will contain two separate cohorts. Part F will focus on patients with advanced or metastatic ER positive breast tumours with alterations of PTEN (restricted to genomic alterations which are predicted to ablate function of the gene, e.g. alterations with known functional significance and/or of most likely therapeutic significance. Each participant will receive AZD5363 as an intermittent regimen of 480 mg twice daily for 4 days on, 3 days off dosing Primary objective for Part C is to investigate the safety and tolerability of AZD5363 in participants with advanced or metastatic estrogen receptor positive (ER+) or human epidermal growth factor receptor 2 positive (HER2+) breast cancer, gynaecological (ovarian, cervical or endometrial) cancer, or other advanced solid cancer that has a PIK3CA mutation. Primary objective for Part D is to investigate the safety and tolerability of AZD5363 in patients with advanced or metastatic ER+ or HER2+ breast cancer, gynaecological (ovarian, cervical or endometrial) or other advanced solid cancer that has an AKT1 mutation or other molecular aberration leading to dysregulation of the PI3K/AKT pathway Primary objective for Part E is to investigate the safety and tolerability of AZD5363 in combination with fulvestrant in patients with advanced or metastatic ER positive breast cancer that has an AKT1 mutation. Primary objective for Part F is to investigate the safety and tolerability of AZD5363 in combination with fulvestrant in patients with advanced or metastatic ER+ positive breast cancer that has a PTEN mutation. Primary study endpoints for Parts C, D, E and F will be safety and tolerability.
Recruiting | Gynecologic Cancers | Multisite
Anthony El-Khoueiry
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A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This is a randomized (individuals assigned to study treatment by chance), open-label (identity of assigned study drug will be known), active-controlled study in adult female patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy. Approximately 670 participants will be enrolled. Patients will be stratified by 4 criteria defined in the protocol and randomly assigned in a 1:1 ratio to the trabectedin+DOXIL combination therapy group (Arm A) or to the DOXIL (pegylated liposomal doxorubicin) monotherapy group (Arm B). During the treatment phase, patients will receive study drug infusions according to 21-day cycles in Arm A and 28-day cycles in Arm B. Treatment will continue until the occurrence of disease progression or unacceptable treatment toxicity, or until 2 cycles beyond a confirmed complete response is documented. Up to 2 additional cycles of study drug are allowed after complete response, at the discretion of the principal investigator. Efficacy assessments will be evaluated using Response Evaluation Criteria in Solid Tumors. Disease assessments, including assessments for patients who discontinue treatment for reasons other than disease progression, will be performed until disease progression, the start of subsequent anticancer therapy, withdrawal of consent, or the clinical cutoff date. Collection of survival status will continue until at least 514 deaths have been observed. Serial pharmacokinetic (PK) samples will be collected in a subset of patients who voluntarily consent to the PK portion of the study. Safety will be monitored throughout the study. An interim analysis of overall survival (OS) will be performed after approximately 308 participants have died. The final analysis of OS will occur when approximately 514 deaths have been observed.
Recruiting | Stomach Cancer | Multisite
A Phase 1/2 Study of the Safety, Tolerability and Efficacy of Epacadostat Administered in Combination with Nivolumab in Select Advanced Cancers
Recruiting | Brain Cancer | Multisite
Heinz-Josef Lenz
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5U-13-1 PhII-129, NCI 9322 A Phase 2 Study of XL184 (Cabozantinib) in Recurrent or Metastatic Endometrial Cancer
Endometrial cancer is the fourth most common cancer diagnosis in North American women. Factors such as age greater than 60, depth of tumor invasion, and involvement of the lower uterus have shown importance in identifying those at a particularly high risk of failing primary therapy. Women whose disease has spread, together with those with more advanced disease at initial presentation have a poor outcome. In contrast with the high 5-year disease free survival in early stage disease, women with disease that has spread can expect about a 20% chance of 5-year disease free survival. Given the diversity existing in this patient population regarding both clinical treatment and treatment response, novel approaches are needed targeting molecular subgroups of this disease that will improve outcomes for patients with endometrial cancer. This is a single arm phase II study to evaluate the activity of the multi-targeted inhibitor cabozantinib in endometrial cancer. Cabozantinib targets receptors that are important for tumor growth, spread, and vessel formation. Patients enrolled for this study will have laboratory confirmed endometrial cancer with documented disease worsening after one line of chemotherapy for disease that has spread or with disease worsening within 12 months of completing chemotherapy after surgery. Chemotherapy and radiation given after surgery will be allowed as well as prior hormonal therapy. In addition, a separate cohort of patients with unusual histology endometrial cancer (including clear cell, carcinosarcoma) will also be enrolled. Dosing of cabozantinib will be continuous (7 days a week) on a 28 day cycle, with response evaluation performed every 2 cycles with CT tumour measurements. The study has a dual primary endpoint of improved response rate and a 12-week progression-free-survival (PFS).The statistical plan to assess effectiveness will only apply to the experimental cohort (serous and endometroid histology patients). Statistical plan is based on effectiveness in serous, endometroid and mixed histology endometrial cancer. A modified Simon two-stage design is planned with a maximum accrual of 36 patients to discriminate between co-primary endpoints of tumor response rates of 30% vs. 10% and 12-week progression-free-survival (PFS) rates of 55% vs. 30% (corresponding to median PFS of 3.4 vs. 1.7 months). Stage I has a planned accrual of 18 patients. If no more than 2 objective responses (no more than 11%), and no more than 6 instances of 12-week PFS (no more than 33%), were observed among the initial 18 patients, the study would be terminated early and declared negative. Otherwise study will proceed to Stage II of accrual to a maximum of 36 patients. If at least 8 objective responses (at least 22%), or at least 16 instances of 12-week PFS (at least 44%), were observed among the 36 evaluable patients, this agent would be considered worthy of further testing in this disease.
Recruiting | Gynecologic Cancers | Multisite
Koji Matsuo
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A Multicentre Phase II Study of AZD1775 Plus Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This is a phase II study of AZD1775 plus chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients will receive AZD1775 plus carboplatin or AZD1775 plus pegylated liposomal doxorubicin (PLD). The primary endpoint for the study is overall response rate (ORR) defined as the proportion of patients achieving a complete or partial tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. Secondary endpoints include assessment of the duration of response (DoR), overall survival (OS), progression-free survival (PFS), disease control rate (DCR), Gynecologic Cancer Intergroup (GCIG) cancer antigen-125 response, safety and tolerability, clinically significant changes in safety-related laboratory parameters, pharmacokinetics (PK) and drug-drug interactions of AZD1775 plus carboplatin and AZD1775 plus PLD. Six (6) patients will be enrolled in the AZD1775 plus carboplatin arm (designated Arm C) in a dose escalation scheme as a safety lead-in cohort. When a safe and tolerable dose of AZD1775 in combination with carboplatin is determined, 17 additional patients will be enrolled to be treated at that dose level. Patients may continue on study as long as they are benefitting, have no evidence of disease progression, and do not meet any criteria for discontinuation or withdrawal. Up to 12 patients will be enrolled in the AZD1775 plus PLD arm (designated Arm D) in a dose escalation scheme as a safety lead-in cohort. When a safe and tolerable dose of AZD1775 in combination with PLD is determined, 17 additional patients will be enrolled to be treated at that dose level. Patients may continue on study as long as they are benefitting, have no evidence of disease progression, and do not meet any criteria for discontinuation or withdrawal. A Safety Review Team (SRT) will assess the safety and tolerability of the first 6 patients in each arm by incidence and severity of adverse events (AEs) after a minimum of 1 treatment cycle as determined by NCI CTCAE v4.03 and the occurrence of pre-defined dose-limiting toxicities (DLTs). Patients must complete Cycle 1 safety evaluations, and return to the study centre for Cycle 2 Day 1 evaluations to be considered evaluable for the safety lead-in. Once the AZD1775 plus carboplatin (Arm C) and AZD1775 plus PLD (Arm D) arms are evaluated as safe and tolerated by the SRT, these arms will continue enrolling until 23 patients have been evaluated for efficacy (i.e., tumour response).
Recruiting | Stomach Cancer | Multisite
Kathleen Moore
GOG 0263: RANDOMIZED PHASE III CLINICAL TRIAL OF ADJUVANT RADIATION VERSUS CHEMORADIATION IN INTERMEDIATE RISK, STAGE I/IIA CERVICAL CANCER TREATED WITH INITIAL RADICAL HYSTERECTOMY AND PELVIC LYMPHADENECTOMY
PRIMARY OBJECTIVES: I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical hysterectomy. SECONDARY OBJECTIVES: I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy. II. To assess differences (across treatment arms) in incidence and severity of therapy-attributed adverse events utilizing the active version of Common Terminology Criteria for Adverse Events (CTCAE). III. To provide assessment of patient risk vs benefit (positive study only). IV. To determine whether post-operative adjuvant CRT improves the health-related quality-of-life (QOL) (compared to RT alone) as measured by Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles (with particular focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual adverse events). TERTIARY OBJECTIVES: I. To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients randomized to post-operative adjuvant CRT compared to RT alone. II. To bank deoxyribonucleic acid (DNA) from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients randomized to post-operative adjuvant CRT compared to RT alone. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks. ARM II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Recruiting | Gynecologic Cancers | Multisite
Huyen Pham
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3R-12-2 Phase II Trial Of Neoadjuvant Bevacizumab With Modified FOLFOX7 In Patients With Stage II And III Rectal Cancer
There were about 40,000 cases of rectal cancer in the United States in 2011. The standard treatment is surgery, but the cancer recurs in 10-20% of cases. To decrease recurrence, chemotherapy and radiation are given before surgery. However, radiation with chemotherapy has not been shown to improve overall survival, so chemotherapy is also given for 3-4 months after surgery. Radiation is also associated with short and long term side effects and has differing effects on survival depending on the stage of disease, but the degree of tumor response after radiation with chemotherapy is associated with survival. Thus, tumor response or complete pathologic response (CPR) appears to be a good indicator for long term outcomes. A previous study has shown that chemotherapy without radiation using FOLFOX (Oxaliplatin, Leukovorin and Fluororacil) and Bevacizumab yields a CPR rate of 27% and does not compromise the removal of the tumor with surgery. This Phase II study will attempt to validate the results of that study using FOLFOX and Bevacizumab without radiation in patients with rectal cancer that has not spread and can be removed surgically. This study will also assess the rate that the tumor recurs and assess specific biomarkers that may be associated with tumor response.Once participants sign the informed consent and are deemed eligible for the study, participants will receive a modified FOLFOX regimen, called mFOLFOX7, with Bevacizumab through a vein in the arm every 2 weeks. Every 2 weeks is called a cycle. During the study, participants will have the following procedures done during each cycle: a physical exam, vital signs, blood tests, performance status, assessment of side effects, review of medications, and tumor assessments with ultrasound and radiographic scans at the end of study treatment before surgery. All participants will stop taking study drug(s) if their disease worsens, they will not have surgery, they have another illness which prevents them from taking the study drug(s), they cannot tolerate the side effects, they withdraw from the study, or their study doctor thinks that being on the study is no longer in their best interest. All participants will be followed every 3 months after stopping the study drug(s) for the first 2 years, and then every 6 months for 3 years.The primary endpoint of this study is complete pathologic response. A two-stage Simon design was used to calculate sample size. All subjects will be analyzed as intent to treat. Biomarkers will be analyzed using a contingency table, bar plots, Fisher's exact test, scatterplots, and two-sample Wilcoxon or t-test. An optimal cut-off value of the continuous biomarker will be chosen to separate patients into 2 groups in term of probability of CPR using the maximal chi-square approach. P value for the associations will be adjusted using bootstrap like simulations.
Recruiting | Colon / Rectal Cancer | Not Multisite
Afsaneh Barzi
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