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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00019019
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 15, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

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.

Condition or disease Intervention/treatment Phase
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 Drug: carboxyamidotriazole Drug: paclitaxel Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Primary Purpose: Treatment
Study Start Date : October 1994
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


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


  • 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


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


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


  • 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


  • Recovery from prior therapy required

Biologic therapy:

  • At least 4 weeks since prior biologic therapy


  • 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


  • At least 4 weeks since prior radiotherapy


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00019019

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
NCI - Medical Oncology Clinical Research Unit
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
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Study Chair: Virginia Kwitkowski, MS, RN, CS, CRNP National Cancer Institute (NCI)
Publications of Results:
Layout table for additonal information Identifier: NCT00019019    
Obsolete Identifiers: NCT00001423
Other Study ID Numbers: 950015
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
recurrent non-small cell lung cancer
recurrent adult Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
recurrent adult brain tumor
small intestine lymphoma
adult brain stem glioma
adult craniopharyngioma
adult medulloblastoma
adult meningioma
adult glioblastoma
stage III melanoma
stage IV melanoma
recurrent melanoma
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IIIC breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Intestinal Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nervous System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases