Carboxyamidotriazole and Ketoconazole in Treating Patients With Advanced Cancers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of carboxyamidotriazole and ketoconazole in treating patients with advanced cancers. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Carboxyamido-triazole; Ketoconazole

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven refractory or recurrent nonhematologic malignancies

• Measurable or evaluable disease by radiographic or clinical examination

PATIENT CHARACTERISTICS:

• Age: 18 and over

• Performance Status: Karnofsky 70-100%

• Absolute neutrophil count at least 2,000/mm3

• Platelet count at least 100,000/mm3

• Bilirubin no greater than 1.5 mg/dL

• SGOT and SGPT no greater than 2.5 times upper limit of normal

• Albumin at least 3 g/dL

• Creatinine no greater than 1.5 mg/dL OR creatinine clearance greater than 60 mL/min

• No concurrent neurotoxicities greater than grade 1 from previous chemotherapy

• No concurrent neuropathy greater than grade 1

• Not pregnant

• Effective contraceptive method must be used by fertile patients during and up to 2 months after study

• No serious uncontrolled medical illness

• No history of active inflammatory bowel disease, ileus, or other chronic malabsorption syndromes

PRIOR CONCURRENT THERAPY:

• No concurrent isoniazid

• No concurrent rifampin

• At least 4 weeks since chemotherapy

• At least 6 weeks since nitrosoureas therapy

• At least 3 months since suramin therapy

• No prior carboxyamidotriazole

• No concurrent steroids (except dose required for adrenal insufficiency)

• No concurrent tamoxifen

• No prior radiotherapy within 4 weeks of study

• No prior total gastrectomy or total ileocolectomy

• No concurrent therapy with H2 antagonists, barbiturates, calcium channel blockers, terfenadine, astemizole, cisapride, digitoxin, quinidine, amiodarone, carbamazepine, imipramine, or antacids

• No concurrent erythromycin