Completed

A Phase I Investigation of Carboxyamido-triazole (CAI) Modulated by Ketoconozole In Patients With Advanced Malignancies

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What is being tested

carboxyamidotriazole

+ chemotherapy

+ ketoconazole

Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 1998
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 7, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003249
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 7, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Chicago Cancer Research Center

Chicago, United StatesOpen University of Chicago Cancer Research Center in Google Maps
CompletedOne Study Center