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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Open-Label, Multi-Center Study of CP-547, 632, an Oral Tyrosine Kinase Inhibitor of VEGFR-2, in Subjects With Recurrent or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, or Fallopian Tube Cancer

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: CP-547,632


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-547,632|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer