Overview

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

Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
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