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Carboxyamidotriazole and Ketoconazole in Treating Patients With Advanced Cancers
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003249
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: May 1998
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003249

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Mark J. Ratain, MD University of Chicago
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Calcium, Dietary
Anti-Infective Agents
Antifungal Agents
Carboxyamido-triazole
Calcium Channel Blockers
Cardiovascular Agents
Ketoconazole

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 02, 2009