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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: chemotherapy; Drug: carboxyamidotriazole

Study type: Interventional

Funder types: NIH

Identifiers

NCT00019461

CDR0000066216

NCI-T97-0112

NCI-98-C-0012

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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