Status:
COMPLETED
CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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), ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00096239
Start Date
December 1 2004
End Date
February 1 2005
Last Update
December 19 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781