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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00019461
Enrollment
Unknown
Registered
2003-01-27
Start date
1998-04-30
Completion date
2007-10-31
Last updated
2013-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

Brief summary

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

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.

Interventions

DRUGchemotherapy

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026