Carboxyamidotriazole and Ketoconazole in Treating Patients With Advanced Cancers

NCT00003249 | Completed Phase 1

• 4 other identifiers: NCI-2012-02265UCCRC-9019NCI-T97-0086CDR0000066129
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

Arm 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.

Drug: carboxyamidotriazole; Drug: chemotherapy; Drug: ketoconazole

Interventions

carboxyamidotriazole DRUG

Arm I

chemotherapy DRUG

Arm I

ketoconazole DRUG

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

carboxyamido-triazole; Drug Therapy; Ketoconazole

Intervention Hierarchy (Ancestors)

Therapeutics; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark J. Ratain, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: June 3, 2004
• Study Start: May 1, 1998
• Primary Completion: December 1, 2001
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

US (1)