Clinical trial · Interventional
Carboxyamidotriazole and Ketoconazole in Treating Patients With Advanced Cancers
A Phase I Investigation of Carboxyamido-triazole (CAI) Modulated by Ketoconozole In Patients With Advanced Malignancies
NCT00003249CI-TRIAL-00009364completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboxyamidotriazole | Drug | — | UNRESOLVED |
| chemotherapy | Drug | Chemotherapy | ALIAS |
| ketoconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: carboxyamidotriazole
- Drug: chemotherapy
- Drug: ketoconazole
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.