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

This study has been completed.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019019
  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.


Condition Intervention 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 I

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Fungal Infections    Hodgkin's Disease    Intestinal Cancer    Kidney Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lung Cancer    Lymphoma    Melanoma    Ovarian Cancer   

Drug Information available for:   Paclitaxel    L 651582   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   70
Study Start Date:   October 1994

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019019

Locations
United States, Maryland
NCI - Medical Oncology Clinical Research Unit    
      Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support    
      Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     Virginia Kwitkowski, MS, RN, CS, CRNP     NCI - Center for Cancer Research-Medical Oncology    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000063881, NCI-95-C-0015F, NCI-CPB-334, NCI-T94-0006N
First Received:   July 11, 2001
Last Updated:   November 22, 2008
ClinicalTrials.gov Identifier:   NCT00019019
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Sezary syndrome
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Urogenital Neoplasms
Lymphoma, large-cell, immunoblastic
Lung Neoplasms
Lymphoma, Large-Cell, Anaplastic
Neuroepithelioma
Kidney Diseases
Endocrine Gland Neoplasms
Non-small cell lung cancer
Astrocytoma
Genital Neoplasms, Female
Breast Neoplasms
Carcinoma
Brain Neoplasms
Lung Diseases
B-cell lymphomas
Anaplastic large cell lymphoma
Nevus
Lymphoma, Non-Hodgkin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Choroid Plexus Neoplasms
Lymphoma, Follicular
Sezary Syndrome
Lymphoma, B-Cell
Lymphoma, large-cell
Burkitt's lymphoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Mitosis Modulators
Neoplasms, Nerve Tissue
Nervous System Diseases
Calcium Channel Blockers
Antimitotic Agents
Cardiovascular Agents
Ileal Diseases
Pharmacologic Actions
Adnexal Diseases
Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Jejunal Diseases
Therapeutic Uses
Tubulin Modulators
Nevi and Melanomas
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on December 03, 2008




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