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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboxyamido-triazole; Paclitaxel

Criteria

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