Carboxyamidotriazole and Ketoconazole in Treating Patients With Advanced Cancers
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unspecified Adult Solid Tumor, Protocol Specific
Intervention: carboxyamidotriazole (Drug); ketoconazole (Drug); chemotherapy (Procedure)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Mark J. Ratain, MD, Study Chair, Affiliation: University of Chicago
Summary
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.
Clinical Details
Official title: A Phase I Investigation of Carboxyamido-Triazole (CAI) Modulated by Ketoconozole In Patients With Advanced Malignancies
Study design: Treatment
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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% 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
Locations and Contacts
University of Chicago Cancer Research Center, Chicago, Illinois 60637, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 1998
Last updated: May 23, 2008
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