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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003249 |
RATIONALE: 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.
PURPOSE: Phase I trial to study the effectiveness of carboxyamidotriazole and ketoconazole in treating patients with advanced cancers.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: carboxyamidotriazole Drug: chemotherapy Drug: ketoconazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Investigation of Carboxyamido-Triazole (CAI) Modulated by Ketoconozole In Patients With Advanced Malignancies |
Estimated Enrollment: | 30 |
Study Start Date: | May 1998 |
OBJECTIVES: I. Determine the maximum tolerated dose of carboxyamidotriazole (CAI) in combination with ketoconazole in patients with advanced malignancies. II. Evaluate the toxic effects, safety, and efficacy of CAI in combination with ketoconazole. III. Determine the modulatory effects of ketoconazole on the pharmacokinetic profile of CAI. IV. Determine a pharmacodynamic model for CAI and ketoconazole with respect to potential gastrointestinal, hematologic, and neurotoxicities.
OUTLINE: This is a dose escalation study. Patients receive oral carboxyamidotriazole (CAI) as a test dose on day
1. Patients receive oral ketoconazole on day 7, followed by CAI plus ketoconazole on day 8. CAI and ketoconazole are administered in combination on day 1 and days 3-28 of the first course. Ketoconazole is administered alone on day 2 of the first course. Subsequent courses begin at 28 day intervals in the absence of disease progression or unacceptable toxic effects. Cohorts of 3 patients are evaluated at each dose level prior to dose escalation. If one of three patients within a cohort experiences dose limiting toxicity (DLT), that dose level is expanded to incorporate six patients. If two or more patients experience DLT, the next lower dose is declared to be the maximum tolerated dose.
PROJECTED ACCRUAL: Up to 30 patients will be accrued for the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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% Life Expectancy: Not specified
Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic:
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 Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Neurologic: No concurrent neurotoxicities greater than grade 1 from previous chemotherapy No concurrent neuropathy greater than grade 1 Other: 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: Biologic therapy: No concurrent isoniazid No concurrent rifampin Chemotherapy: At least 4 weeks since chemotherapy At least 6 weeks since nitrosoureas therapy At least 3 months since suramin therapy No prior carboxyamidotriazole Endocrine therapy: No concurrent steroids (except dose required for adrenal insufficiency) No concurrent tamoxifen Radiotherapy: No prior radiotherapy within 4 weeks of study Surgery: No prior total gastrectomy or total ileocolectomy Other: No concurrent therapy with H2 antagonists, barbiturates, calcium channel blockers, terfenadine, astemizole, cisapride, digitoxin, quinidine, amiodarone, carbamazepine, imipramine, or antacids No concurrent erythromycin
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637 |
Study Chair: | Mark J. Ratain, MD | University of Chicago |
Study ID Numbers: | CDR0000066129, UCCRC-9019, NCI-T97-0086 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003249 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Calcium, Dietary Anti-Infective Agents Antifungal Agents Carboxyamido-triazole |
Calcium Channel Blockers Cardiovascular Agents Ketoconazole |
Membrane Transport Modulators Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antifungal Agents |
Carboxyamido-triazole Calcium Channel Blockers Cardiovascular Agents Ketoconazole Pharmacologic Actions |