Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00019461


Primary Contact:

Study Chair
Mahrukh Hussain, MD
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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