Overview
Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Status:
Completed
Completed
Trial end date:
2007-10-01
2007-10-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
National Cancer Institute (NCI)Treatments:
Carboxyamido-triazole
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