Assessment of Novel Biomarkers in Patients With Metastatic Castration Resistant Prostate Cancer
I. Perform molecular analysis of plasma samples from 25 patients with metastatic prostate
cancer collected before and during treatment of the disease with abiraterone acetate
(Zytiga) or enzalutamide (Xtandi).
II. Perform molecular characterization of circulating tumor cells (CTCs) and plasma
collected from 75 patients with progressing advanced metastatic prostate cancer.
OUTLINE: Patients are assigned to 1 of 2 groups based on the timing of specimen collection.
GROUP I: Previously collected plasma samples are analyzed for ctDNA via polymerase chain
reaction (PCR) and next generation sequencing (NSG).
GROUP II: Patients undergo collection of blood samples before and following systemic therapy
for analysis of CTC enumeration, ribonucleic acid (RNA) expression, and ctDNA via PCR and
A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
I. To evaluate the effect of a brief educational program on colorectal cancer knowledge
acquisition in a 3-arm randomized clinical trial (Control Group: standard of care; Treatment
Group 1: cancer education; Treatment Group 2: mindfulness + cancer education) comparing
visual/written educational material with and without mindfulness training to the standard of
II. To determine the priming effect of a brief mindfulness training on retaining knowledge
of colorectal cancer education.
III. To determine the joint effect of colorectal cancer education delivered to both the
patient and a caregiver on the overall colorectal cancer knowledge.
I. To examine the relative changes in psychobiological variables (stress, anxiety,
depression, mindfulness, fatigue, life benefit) from pre (T0) to post (T1) intervention in
the 3 arms of the clinical trials.
II. To measure changes in salivary cortisol levels as an indicator of acute stress
reactivity across 4 time points across a one-hour period (i.e., 0 min, 20 min, 40 min, 60
min) during active chemotherapy (T1).
III. To determine the moderating effect of baseline peripheral levels of inflammation
(interleukin-1 [IL-1], IL-6, c-reactive protein [CRP] and tumor necrosis factor alpha
[TNFa]) on the trajectory of salivary cortisol reactivity.
OUTLINE: Patients and caregivers are randomized to 1 of 3 groups.
GROUP I: Patients and caregivers receive standard of care.
GROUP II: Patients and caregivers receive a 20-minute self-playing interactive educational
GROUP III: Patients and caregivers receive a 20-minute self-playing interactive educational
video brochure and watch a 20-minute interactive mindfulness exercise video.
Recruiting | Colon / Rectal Cancer | Not Multisite
Combined Exercise Program for Early Breast Cancer Survivors
I. To determine whether a 16-week exercise intervention will improve components of
metastasis (MetS) in breast cancer survivors soon after completion of cancer-related
treatments by measuring changes in body composition, waist circumference, blood pressure,
and serum levels of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c
II. To determine whether a 16-week exercise intervention will improve physical fitness in
breast cancer survivors soon after completion of cancer-related treatments by measuring
cardiorespiratory fitness and muscle strength.
III. To assesses the feasibility of a supervised exercise intervention in early breast
IV. To determine whether a 16-week exercise intervention will result in a reduction in
adipose tissue inflammation in obese breast cancer survivors soon after completion of
cancer-related treatments by measuring ATM phenotype and ATM cytokine expression.
V. To determine whether breast cancer survivors can maintain positive benefits of an
exercise intervention following a 12-week follow-up period by measuring changes in body
composition, waist circumference, blood pressure, and serum levels of insulin, glucose,
lipids, C-reactive protein, and HbA1c, cardiorespiratory fitness and muscle strength.
Patients are randomized to 1 of 2 arms.
Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks.
Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes
thrice weekly and are encouraged to participate in a home-based exercise session over 30-45
minutes once weekly for 16 weeks.
0C-12-5 An Open Label Multicentric Phase 1 Study of Oral PI3K/mTOR Inhibitor P7170 in Patients with Advanced Refractory Solid Tumors
An open label multicentric Phase 1 study of oral PI3K/mTOR inhibitor P7170 in patients with
advanced refractory solid tumors.The study will follow an Accelerated Titration Design (ATD)
with 100% dose increments until significant toxicity as described below; followed by
standard dose titration with 40% dose increments. Dose and schedule (alternate dosing
regimen eg. OD, BID, intermittent) will be determined by the dose escalation outlined in the
protocol and considering pharmacokinetics of the study drug determined from earlier cohorts.
Suspended | Any Cancer Condition or Solid Tumor | Multisite
SWOG-S1313: A Phase Ib/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) versus Modified FOLFIRINOX Alone in Patients with Good Performance Status Metastatic Pancreatic Adenocarcinoma.
The outcome of patients with metastatic pancreatic cancer remains very poor. Until recently, gemcitabine was the only agent with reproducible activity and resulting in a median survival of only 5-6 months. Despite attempts to improve the outcome by adding a second agent to gemcitabine, no worthwhile progress has been made thus far. There are grounds for optimism as two new regimens (gemcitabine/nab-paclitaxel and FOLFIRINOX) have emerged as front line options. The study drug, recombinant pegylated human hyaluronidase (PEGPH20) is widely used to enhance subcutaneous dispersion and absorption of various agents. It has shown to inhibit tumor growth, and enhance effects of chemotherapy in mouse models of cancer. Plus, other studies have shown the PEGPH20 can damage the outer layer of a tumor which can let more chemotherapy reach the tumor and possibly increase effectiveness. The study will be conducted in two sequential parts. A participant may be enrolled to either the Phase I Portion or the Phase II Portion. The Phase I portion will be a dose de-escalation clinical trial with two dose levels of PEGPH20. For the Phase II portion of the study (which will be temporarily closed to define the dose of PEGPH20) will have two treatment arms (Arm 1-mFolfirinox and Arm 2-PEGPH20+mFolfirinox). All study participants will be followed until death or 3 years after registration. The primary Phase 1 objective is to assess the safety of mFOLFIRINOX in combination with PEGPH20 and select the optimal dose of PEGPH20 for the Phase II portion in patients with metastatic pancreatic adenocarcinoma. While the Phase II objective is to assess the overall survival of patients with metastatic pancreatic adenocarcinoma treated with mFOLFIRINOX + PEGPH20 compared to those treated with mFOLFIRINOX alone. Assuming a 10% ineligibility rate, 7-20 study participants will be accrued to yield 6-18 eligible participants for the Phase I portion of the trial and 152 participants will be accrued to yield 138 eligible participants for the Phase II portion of the trial. The study will require 2 years of accrual, 1.5 years of follow-up, type 1 error of 10%, and 80% power. For the Phase II trial, study participants will be stratified according to Zubrod Performance Status: 0 vs. 1. The primary analysis of overall survival will be conducted in all eligible patients according to the intent-to-treat principle, using the logrank test. The final analysis will take place upon the observation of approximately 110 deaths. An interim analysis will be performed when one-third of the events (approximately 37 deaths) have been observed.
Active, not recruiting | Pancreatic Cancer | Multisite
0C-12-1-A Phase 1 Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of Crizotinib in Advanced Cancer Patients [A8081012]
This is a research study for advanced cancer with varying degree of liver function (normal, mild impairment, moderate impairment or severe impairment). The main purposes of this research study are to see whether a newly approved drug, crizotinib (Xalkori), can be used in patients with liver function that is not normal and to see whether crizotinib can prevent or slow down your cancer from growing, and to assess any side effects that you may have. Some other purposes of this study are to measure how much crizotinib is in your blood, and to provide dosing recommendations for patients with impaired liver function. Crizotinib is approved in the United States (US) and is available by prescription for non-small cell lung cancer (NSCLC) patients with Anaplastic Lymphoma Kinase (ALK) mutation. However, the use of crizotinib in this study is experimental. Crizotinib is not currently approved to treat other advanced cancer patients with unclear ALK status and/or with liver function that is not normal. . The participants of this study will be in this study until their disease progresses (gets worse), they experience unacceptable side effects or they withdraw consent. There will be about 50 advanced cancer patients enrolled in this study. The study is being done at about 3-5 different research sites in US. About 45 participants will take part at USC. This is a multicenter, open-label, non-randomized, phase 1 study. The endpoints are how the drug behaves in the body when taken (pK), effectiveness and safety of the study drug. There will be 5 groups (Groups A1, A2, B, C and D) involved in this study. Groups A1 and A2 have normal liver functions. Group A1 will match Group B(mild) and Group A2 will match Group C(moderate).The study drug is given by mouth and should be taken at approximately the same time each day on a continuous daily dosing.One-way analysis of variance (ANOVA) will be used for statistical analysis. Individual concentration of the study drug in the blood will be listed and summarized. The safety analysis population will include all enrolled patients who receive at least one does of crizotinib. The safety analysis population will be the primary population for evaluating patient characteristics, treatment administration and safety. Safety data will be reviewed on an ongoing basis during the study.
Recruiting | Any Cancer Condition or Solid Tumor | Multisite
2L-14-1 Genomics of Young Lung Cancer Study
I. To perform comprehensive genomic analysis of young lung cancer patients' samples to
facilitate delivery of targeted therapies and clinical trial enrollment.
II. To characterize the impact of young age at lung cancer diagnosis on the genomic
landscape of primary lung cancer.
III. To establish a prospective registry of young lung cancer patients for both tumor and
germline next generation sequencing.
Tissue and blood samples are analyzed via next generation sequencing and whole exome
After completion of study, patients are followed up every 3 months for up to 3 years.
Phase II Study of Metformin in a Pre-prostatectomy Prostate Cancer Cohort
I. To determine the effect of 4-12 weeks of metformin (metformin hydrochloride) intervention
on cell proliferation in the prostatectomy tissue.
I. To determine the effect of metformin intervention on prostate tissue bioavailability of
II. To determine the effect of metformin intervention on apoptosis and angiogenesis in the
III. To determine the effect of metformin intervention on potential molecular targets of
metformin including activated protein kinase (AMPK) activation, mammalian target of
rapamycin (mTOR) regulation, and cell cycle regulation in the prostatectomy tissue.
IV. To determine the effect of metformin intervention on changes in systemic hormones and
growth factors that have been shown to be modulated by metformin in other patient
populations including fasting glucose, fasting insulin, insulin-like growth factor axis,
testosterone, and sex hormone binding globulin (SHBG).
V. To determine the effect of metformin intervention on changes in prostate-specific antigen
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD)
for 4-12 weeks.
ARM II: Patients receive placebo PO QD for 4-12 weeks.
Patients in both arms undergo surgery one day after completion of treatment.
After completion of study treatment, patients are followed up within 30 days of surgery.
4B-11-4 A Phase I/II Trial of AEZS-108 in Locally Advanced Unresectable or Metastatic LHRH Positive Urothelial Carcinoma Patients who Failed Platinum Based Chemotherapy
AEZS-108 is an investigational drug, combining luteinizing hormone-releasing hormone (LHRH),
an hormone and doxorubicin (a drug approved to treat different types of cancer).
Some tumors, such as those found in the urinary system (also called urothelial carcinomas),
have LHRH hormone receptors to which the LHRH hormone part of AEZS-108 is attracted.
AEZS-108 is expected to work by accumulating mostly on the surface of cancer cells that have
LHRH hormone receptors and by delivering doxorubicin more directly into the cells to kill
them. This would allow the use doxorubicin at lower doses and thus would cause less
In the first part of the study, the appropriate dose of AEZS-108 will be determined based on
its side effects. The best dose will be the highest one without severe side effects.
In the second part of the study, this best dose of AEZS-108 will be given to determine its
efficacy to stop the tumor from progressing.