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Combination Chemotherapy in Treating Men With Germ Cell Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00003643
Recruitment Status : Unknown
Verified March 2012 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : March 6, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date March 6, 2012
Study Start Date  ICMJE October 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Failure-free survival as measured by Logrank
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery
  • Overall survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
  • Disease-free survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
  • Toxicity as measured by NCI-CTC v2.0 at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
  • Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2
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 Combination Chemotherapy in Treating Men With Germ Cell Cancer
Official Title  ICMJE Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer
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. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.

PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.

Detailed Description

OBJECTIVES:

Phase II

  • Compare the complete response rates in men with intermediate prognosis germ cell cancer treated with bleomycin, cisplatin, and etoposide (BEP) vs bleomycin, cisplatin, etoposide, and paclitaxel (T-BEP).
  • Define the toxicity profile of T-BEP in these patients.

Phase III

  • Compare the disease-free survival of patients treated with these regimens.
  • Compare the complete response rates and overall survival of patients treated with these regimens.
  • Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens.
  • Compare the acute and intermediate (1-2 years) side effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (seminoma vs non-seminoma) and hospital. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cisplatin IV and etoposide IV on days 1-5 and bleomycin IV on days 1, 8, and 15.
  • Arm II: Patients receive cisplatin, etoposide, and bleomycin as in arm I and paclitaxel IV over 3 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 6-15.

In both arms, treatment repeats every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before treatment randomization and at 1 and 2 years after randomization.

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 84-164 patients (42-82 per treatment arm) will be accrued for the phase II study. A total of 498 patients (249 per treatment arm) will be accrued for the phase III study. Accrual will be completed within 4 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Extragonadal Germ Cell Tumor
  • Teratoma
  • Testicular Germ Cell Tumor
Intervention  ICMJE
  • Biological: bleomycin sulfate
  • Biological: filgrastim
  • Drug: cisplatin
  • Drug: etoposide
  • Drug: paclitaxel
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
498
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically proven germ cell cancer

    • Seminoma
    • Non-seminoma
    • Combined
  • Intermediate prognosis

    • Non-seminoma:

      • Testis/retroperitoneal primary
      • No non-pulmonary visceral metastases
      • Meets 1 of the following criteria:

        • Alpha-fetoprotein (AFP) 1,000- 10,000 IU/L
        • Human chorionic gonadotropin (hCG) 5,000-50,000 IU/L
        • Lactic dehydrogenase (LDH) 1.5 times-10 times upper limit of normal (ULN)
    • Seminoma:

      • Any primary site
      • Any LDH and HCG
      • AFP normal
      • Non-pulmonary visceral metastases present

PATIENT CHARACTERISTICS:

Age:

  • 16 to 50

Sex:

  • Male

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.25 times ULN
  • AST no greater than 2 times ULN

Renal:

  • Creatinine clearance at least 40 mL/min (unless due to obstructive uropathy which can be relieved by nephrostomy)

Other:

  • No pre-existing neuropathy
  • No other malignancy except basal cell skin cancer
  • No other serious illness or medical conditions incompatible with the protocol

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 16 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Norway,   Poland,   Slovakia,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003643
Other Study ID Numbers  ICMJE EORTC-30983
EORTC-30983
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ronald De Wit, MD, PhD Daniel Den Hoed Cancer Center at Erasmus Medical Center
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date March 2012

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