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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00019019
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Institutes of Health Clinical Center (CC)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Virginia Kwitkowski, MS, RN, CS, CRNP
Principal Investigator Affiliation National Cancer Institute (NCI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Address

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182

Bethesda, Maryland

Status

Address

NCI - Medical Oncology Clinical Research Unit

Bethesda, Maryland, 20892