Carboxyamidotriazole and Paclitaxel in Treating Patients With Advanced Solid Tumors or Refractory Lymphomas

NCT ID: NCT00019019

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-10-31
• Study Completion Date: 2006-07-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or refractory lymphomas.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose of paclitaxel when combined with carboxyamidotriazole in patients with advanced solid tumors or refractory lymphomas.
• Determine the pharmacokinetics and toxicities of this regimen in these patients.
• Identify diseases for which this combination appears active.

OUTLINE: This is a dose escalation study.

Patients receive oral carboxyamidotriazole (CAI) daily with paclitaxel IV over 3 hours on day 8 and every 3 weeks thereafter. Course 1 is 28 days and all other subsequent courses are 21 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses of treatment.

Sequential dose escalation of CAI is followed by sequential dose escalation of paclitaxel. Dose escalation in cohorts of 3 to 6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Conditions

Brain and Central Nervous System Tumors; Breast Cancer; Kidney Cancer; Lung Cancer; Lymphoma; Melanoma (Skin); Ovarian Cancer; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carboxyamidotriazole

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3
• Hematocrit at least 27%

Hepatic:

• Liver function tests no greater than 2 times upper limit of normal
• Bilirubin normal
• PT or PTT no greater than 1.25 times upper limit of normal
• Clotting parameters normal
• No concurrent anticoagulants other than 1 mg of warfarin per day for prophylaxis

Renal:

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 45 mL/min
• No kidney obstruction

Cardiovascular:

• No cardiac conduction defect requiring antiarrhythmics
• No evidence of myocardial infarction or other myocardial damage within past 6 months

Other:

• HIV negative
• No concurrent infection
• No guaiac-positive stool test
• No neuropathy greater than grade I (unless associated with fixed-deficit primary brain tumors)
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

• Recovery from prior therapy required

Biologic therapy:

• At least 4 weeks since prior biologic therapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks since mitomycin, nitrosoureas, or carboplatin)
• No progression on carboxyamidotriazole or paclitaxel
• At least 6 months between treatment and relapse

Endocrine therapy:

• At least 4 weeks since prior hormonal therapy
• No concurrent corticosteroids except as physiologic replacement

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• Not specified

Other:

• At least 1 week since prior therapeutic antibiotics
• Concurrent prophylactic antibiotics allowed except imidazole antifungals (e.g., ketoconazole, fluconazole)
• No concurrent calcium channel blockers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

Virginia Kwitkowski, MS, RN, CS, CRNP

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

NCI - Medical Oncology Clinical Research Unit

Bethesda, Maryland, United States

Countries

United States

References

Kohn EC, Reed E, Sarosy GA, Minasian L, Bauer KS, Bostick-Bruton F, Kulpa V, Fuse E, Tompkins A, Noone M, Goldspiel B, Pluda J, Figg WD, Liotta LA. A phase I trial of carboxyamido-triazole and paclitaxel for relapsed solid tumors: potential efficacy of the combination and demonstration of pharmacokinetic interaction. Clin Cancer Res. 2001 Jun;7(6):1600-9.

Reference Type: RESULT

PMID: 11410496 (View on PubMed)

Other Identifiers

95-C-0015

Identifier Type: -

Identifier Source: secondary_id

NCI-CPB-334

Identifier Type: -

Identifier Source: secondary_id

NCI-T94-0006N

Identifier Type: -

Identifier Source: secondary_id

CDR0000063881

Identifier Type: -

Identifier Source: secondary_id

950015

Identifier Type: -

Identifier Source: org_study_id

NCT00001423

Identifier Type: -

Identifier Source: nct_alias