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

Breast Cancer Clinical Trial

Official title:

A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00019019
• Other study ID #: 950015
• Secondary ID: 95-C-0015NCI-CPB
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2001
• Last updated: March 14, 2012
• Start date: October 1994
• Est. completion date: July 2006

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00001423

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically diagnosed solid tumor (i.e., breast and ovarian epithelial carcinomas) or lymphoma

• Slides reviewed at the NCI Laboratory of Pathology

• Failure on therapy of proven efficacy for the disease

• Prior therapy not required for the following metastatic diseases:

• Melanoma

• Non-small cell lung cancer

• Renal cell carcinoma

• No brain metastases

• Primary brain tumors (such as glioblastoma multiforme) with stable neurologic deficits allowed

• Measurable or evaluable disease required

• Demonstrated by physical exam or on radiograph within 2 weeks prior to initiation of treatment OR

• Elevated PSA associated with prostate cancer

• Other marker-only disease ineligible

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• carboxyamidotriazole

• paclitaxel

Locations

Country	Name	City	State
United States	NCI - Medical Oncology Clinical Research Unit	Bethesda	Maryland
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 th — View Citation