Expired Study
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Los Angeles, California 90095


RATIONALE: CP-547,632 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. PURPOSE: This phase II trial is studying how well CP-547,632 works in treating patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Study summary:

OBJECTIVES: Primary - Determine the efficacy of CP-547,632, in terms of clinical response benefit (CA 125 response [complete response (CR) or partial response (PR)] or stable disease ≥ 16 weeks), in patients with recurrent or persistent small-volume ovarian epithelial, primary peritoneal serous, or fallopian tube cancer. Secondary - Determine progression-free survival of patients treated with this drug. - Determine CA 125 response (CR or PR) rate in patients treated with this drug. - Determine duration of CA 125 response in patients treated with this drug. - Determine the safety of this drug in these patients. - Correlate the steady state plasma concentration of this drug with efficacy and toxicity in these patients. - Correlate clinical outcome with an angiogenic profile derived from measurement of serum vascular endothelial growth factor, basic fibroblast growth factor, and interleukin-8 in patients treated with this drug. - Determine changes in the Hospital Anxiety and Depression Scale (HADS) in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients receive oral CP-547,632 once daily on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1 year.


DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, primary peritoneal serous, or fallopian tube cancer - Recurrent or persistent disease - Elevated CA 125, defined as ≥ 40 U/mL on 2 separate consecutive measurements taken ≥ 1 week apart - No definitive disease OR small-volume disease (≤ 2 cm by spiral or conventional CT scan or clinical exam) - Asymptomatic disease PATIENT CHARACTERISTICS: Age - 26 and over (age 18 to 25 allowed provided there is closure of the epiphyses on radiography) Performance status - ECOG 0-1 Life expectancy - More than 6 months Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - No bleeding disorders - No hemorrhage ≥ grade 2 within the past 12 months Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 times ULN - ALT and/or AST ≤ 2.5 times ULN - Albumin ≥ 3.2 g/dL - PT/PTT ≤ 1.5 times ULN - INR ≤ 1.5 Renal - Creatinine ≤ 1.5 times ULN OR - Creatinine clearance ≥ 60 mL/min Cardiovascular - QTc ≤ 460 msec by ECG - No unstable angina within the past 6 months - No decompensated congestive heart failure within the past 6 months - No myocardial infarction within the past 6 months - No serious cardiac arrhythmias or conduction abnormalities, including any history of recurrent ventricular arrhythmia, within the past 6 months - No cardiomyopathy - No history of syncope associated with arrhythmia - No uncontrolled hypertension within the past 3 weeks, defined as systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg on ≥ 2 of 3 blood pressure readings taken ≥ 5 minutes apart - No thrombotic cardiovascular events, including transient ischemic attacks, within the past 12 months Gastrointestinal - Able to take oral medication - No malabsorption syndromes - No active gastrointestinal bleeding (hematemesis, hematochezia, or melena), unrelated to cancer, within the past 3 months - No requirement for IV alimentation Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No active infection - No uncontrolled diabetes - No dementia, altered mental status, or uncontrolled psychiatric illness that would preclude giving informed consent or study compliance - No other serious uncontrolled medical disorder that would preclude study participation - No other active malignancy within the past 3 years except treated limited stage basal cell or squamous cell skin cancer or carcinoma in situ of the breast or cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No prior exposure to mouse antibodies - No prior vascular endothelial growth factor (VEGF) or VEGF-receptor targeted therapy - No other prior antiangiogenic anticancer therapy, including thalidomide - No concurrent prophylactic colony-stimulating factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF]) - No concurrent immunotherapy Chemotherapy - Prior chemotherapy allowed provided patient received only a first-line platinum-based chemotherapy regimen with or without systemic consolidation chemotherapy - At least 3 weeks since prior chemotherapy and recovered (excluding alopecia) - No concurrent chemotherapy Endocrine therapy - At least 3 weeks since prior hormonal therapy for ovarian cancer and recovered - Concurrent hormone replacement therapy allowed - No concurrent chronic oral or IV corticosteroids - No concurrent hormonal therapy, including tamoxifen Radiotherapy - No concurrent radiotherapy Surgery - More than 4 weeks since prior major surgical procedure - No prior gastric resection Other - More than 3 weeks since prior investigational therapy - More than 4 weeks since prior major medical interference with the peritoneum or pleura - More than 3 months since prior treatment for active ulcer disease - No prior consolidation intraperitoneal therapy using cytotoxic agents for ovarian cancer - No concurrent antiarrhythmics - Beta blockers or calcium channel blockers used for other indications allowed - No concurrent grapefruit juice - No concurrent therapeutic anticoagulant therapy or chronic daily aspirin > 325 mg/day - Concurrent low-dose anticoagulants for maintenance of central venous access allowed - No other concurrent experimental or anticancer therapy for the primary disease



Primary Contact:

Principal Investigator
Mark D. Pegram, MD
Jonsson Comprehensive Cancer Center

Backup Contact:


Location Contact:

Los Angeles, California 90095
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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