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

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ClinicalTrials.gov Identifier: NCT00019019
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 15, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date  ICMJE July 11, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date March 15, 2012
Study Start Date  ICMJE October 1994
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carboxyamidotriazole and Paclitaxel in Treating Patients With Advanced Solid Tumors or Refractory Lymphomas
Official Title  ICMJE A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: carboxyamidotriazole
  • Drug: paclitaxel
Study Arms  ICMJE Not Provided
Publications * 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 the combination and demonstration of pharmacokinetic interaction. Clin Cancer Res. 2001 Jun;7(6):1600-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February¬†20,¬†2007)
70
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00019019
Other Study ID Numbers  ICMJE 950015
95-C-0015
NCI-CPB-334
NCI-T94-0006N
CDR0000063881
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institutes of Health Clinical Center (CC)
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Virginia Kwitkowski, MS, RN, CS, CRNP National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP