CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: Female

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 CP-547,632 works in treating patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

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