Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Detailed Description
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OBJECTIVES: Determine the clinical outcome in patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with carboxyamidotriazole. OUTLINE: Patients receive oral carboxyamidotriazole daily beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 2 years.

Official Title
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A Phase II Trial of Orally Administered CAI for Patients With Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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

Intervention / Treatment
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* Drug: carboxyamidotriazole
* Drug: chemotherapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer Measurable disease by physical exam, radiography, peritoneoscopy, or laparoscopy No more than 4 weeks since prior peritoneoscopy No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 4 months Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL AND/OR Hematocrit at least 27% Hepatic: SGOT/SGPT no greater than 3 times upper limit of normal Bilirubin normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No history of symptomatic cardiac dysrhythmias requiring medication At least 6 months since prior myocardial infarction No unstable or newly diagnosed angina Pulmonary: No obstructive lung disease requiring oxygen therapy Other: Not pregnant or nursing HIV negative Must be able to take oral medication No concurrent medical condition (e.g., impending bowel obstruction) No grade 2 or greater residual peripheral neuropathy No active infection No other prior or concurrent invasive malignancy within the past 5 years No history of acute visual loss other than that associated with retinal detachment PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior cytokine therapy No concurrent cytokine therapy to maintain WBC count Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carboplatin, or mitomycin) No other concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy No concurrent corticosteroids at doses greater than physiological replacement doses No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: No more than 3 prior treatment regimens At least 1 week since prior systemic antibiotics for infection No chronic antifungal treatment with antimycotic imidazoles No concurrent alternative therapies

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboxyamidotriazole|nan|
|Drug: chemotherapy|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, fallopian tube cancer, primary peritoneal cavity cancer