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Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor

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ClinicalTrials.gov Identifier: NCT00021047
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 8, 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 8, 2012
Study Start Date  ICMJE July 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00021047 on ClinicalTrials.gov Archive Site
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 Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor
Official Title  ICMJE A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin, carboplatin, and capecitabine in treating patients who have unresectable locally advanced, metastatic, or recurrent solid tumor.

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose and the recommended phase II dose of capecitabine administered with epirubicin and carboplatin in patients with unresectable locally advanced, metastatic, or recurrent solid tumors.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the pharmacokinetics (PK) of capecitabine and correlate these PK parameters with clinical toxicity of this regimen in these patients.
  • Correlate end-of-infusion levels of epirubicin and its metabolites with epirubicin dose and clinical toxicity of this regimen in these patients.
  • Determine the possible correlation between polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity of this regimen in these patients.
  • Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of capecitabine.

Patients receive epirubicin IV over 2 hours and carboplatin IV over 30 minutes on day 1 and oral capecitabine twice daily on days 2-5, 8-12, and 15-19. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 24 additional patients are treated at the recommended phase II dose.

PROJECTED ACCRUAL: A total of 3-45 patients (24 patients for phase II) will be accrued for this study within 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Esophageal Cancer
  • Extrahepatic Bile Duct Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Liver Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Drug: capecitabine
  • Drug: carboplatin
  • Drug: epirubicin hydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor

    • Progressive disease on standard therapy, including:

      • Locally advanced, unresectable primary or recurrent tumor OR
      • Metastatic disease
  • Previously untreated metastatic cancer for which study regimen represents reasonable initial chemotherapy with palliative intent (e.g., metastatic gastric cancer, hepatobiliary cancer, or cancers for which no effective standard therapy exists) allowed
  • Phase II portion:

    • Diagnosis of cancer of the upper aerodigestive tract (head and neck, esophagus, stomach, or hepatobiliary)
    • No potential curative treatment options including surgery, radiotherapy, chemoradiotherapy, or combination chemotherapy
    • No leukemia or lymphoma
    • No primary CNS malignancies or CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.6 mg/dL

Cardiovascular:

  • LVEF at least 50%
  • No symptomatic congestive heart failure
  • No unstable angina
  • No cardiac arrhythmia

Other:

  • No serious concurrent medical illness that would preclude study participation
  • No active infections requiring IV antibiotic therapy
  • No history of allergy to platinum compounds, mannitol, or antiemetics used with study drugs
  • No history of severe intolerance to fluorouracil
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • More than 4 weeks since prior immunotherapy and recovered

Chemotherapy:

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior cumulative doxorubicin dose of more than 300 mg/m2

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy and recovered
  • At least 8 weeks since prior strontium chloride Sr 89

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery

Other:

  • At least 4 weeks since prior sorivudine or brivudine
  • No concurrent sorivudine or brivudine
  • No concurrent cimetidine
  • No concurrent antiretroviral therapy for HIV-positive patients
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 NCT00021047
Other Study ID Numbers  ICMJE 010172
NCI-01-C-0172
MB-NAVY-00-07
MB-NAVY-B01-008
CDR0000068741
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
Investigator: Brian P. Monahan, MD, FACP National Cancer Institute (NCI)
Study Chair: Eva Szabo, MD 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