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SWOG-S1005: A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer

Description

PRIMARY OBJECTIVES: I. To estimate the overall survival (OS) for patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma treated with MK-2206 (Akt inhibitor MK2206). SECONDARY OBJECTIVES: I. To estimate the progression free survival (PFS) in this patient population. II. To estimate the response rate (confirmed and unconfirmed complete response [CR] and partial response [PR] by Response Evaluation Criteria In Solid Tumors [RECIST] 1.1) in this patient population. III. To assess the frequency and severity of toxicity associated with this regimen. OUTLINE (CLOSED TO ACCRUAL 05/01/13): Patients receive Akt inhibitor MK2206 orally (PO) every other day on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 2 years.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • Inclusion Criteria:
  • Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction that has progressed after first-line treatment, or is recurrent within 6 months after receiving adjuvant therapy; patients must have had exactly one prior systemic treatment regimen; previous adjuvant (chemotherapy [chemo]) radiotherapy is permitted; prior chemotherapy given concurrently with radiation for radiosensitization is not considered one prior systemic regimen
  • Patients must have measurable disease; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
  • Patients must not have known brain metastases
  • Patients must not have received chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
  • Patient must not have received prior treatment with a phosphatidylinositol 3 (PI3), v-akt murine thymoma viral oncogene homolog 1 (AKT) or mechanistic target of rapamycin (Mtor) inhibitor for any reason
  • All toxicities from prior therapy must have resolved to =< grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) prior to registration
  • Patients must not be receiving or planning to receive any other investigational agents
  • Patients must be able to tolerate oral medications and must not have malabsorption or chronic diarrhea (CTCAE version 4.0 grade 2 or higher); administration through a feeding tube is not permitted
  • Hemoglobin >= 9 g/dL
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin =< institutional upper limit of normal (IULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 x IULN; patients with liver metastases must have AST and ALT =< 5 x IULN
  • Patients must have adequate kidney function as evidenced by at least ONE of the following:
  • Serum creatinine (mg/dL) =< IULN obtained within 14 days prior to registration
  • Calculated creatinine clearance > 50 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration
  • Patients must have international normalized ratio (INR) =< 1.2 unless taking therapeutic doses of warfarin; this result must be obtained within 14 days prior to registration
  • Patients must have fasting blood sugar =< 150 mg/dL within 28 days prior to registration
  • Patients must have hemoglobin A1C < 7% within 28 days prior to registration
  • Patients must have an electrocardiogram (ECG) within 28 days prior to registration; patients must have corrected QT interval (QTcF) (by Fridericia's calculation) < 450 msec (male) or < 470 msec (female)
  • Patients must have a Zubrod performance status of 0-1
  • Patient must not have any of the following: a history of congenital long QT syndrome; use of concomitant medications that could prolong the QTc interval; New York Heart Association class III or IV heart failure; history of myocardial infarction within 6 months prior to registration; uncontrolled dysrhythmias; poorly controlled angina; resting heart rate =< 50 bpm (bradycardia)
  • Patients must not be receiving concurrent treatment with drugs that are strong inducers or inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4); patients must be able to safely discontinue treatment with these agents for >= 2 weeks prior to beginning protocol therapy
  • Patient must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
  • Patient must not be pregnant or nursing; women/men of reproductive potential must have agreed to use two forms of contraception for the duration of protocol treatment and for one month after discontinuation of MK-2206; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any time a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Sites

  • Washington

    • Pacific Medical Center-First Hill, Seattle, Washington, 98104
    • Evergreen Hospital Medical Center, Kirkland, Washington, 98033
  • Kansas

    • Kansas City Cancer Center-West, Kansas City, Kansas, 66112
    • Kansas City Cancer Center-Shawnee Mission, Shawnee Mission, Kansas, 66204
  • Texas

    • Saint Luke's Episcopal Hospital, Houston, Texas, 77030
    • Veterans Administration Medical Center, Houston, Texas, 77030
  • Missouri

    • Saint Louis University Hospital, Saint Louis, Missouri, 63110
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