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Status:

TERMINATED

Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Extragonadal Germ Cell Tumor

Testicular Germ Cell Tumor

Eligibility:

MALE

18-120 years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet k...

Detailed Description

OBJECTIVES: Primary * Compare the overall survival of men with progressive or recurrent metastatic germ cell tumors treated with paclitaxel, ifosfamide, and cisplatin vs vinblastine, ifosfamide, and...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed germ cell tumor (GCT), including 1 of the following primary tumor sites:
  • Seminoma
  • Testis
  • Retroperitoneum
  • Mediastinum
  • Other extragonadal site
  • Nonseminoma
  • Testis
  • Retroperitoneum
  • Other extragonadal site
  • No tumor of the mediastinum
  • Must have evidence of metastatic disease, including either of the following:
  • Unidimensionally measurable lesions
  • At least 20 mm by conventional techniques (e.g., physical exam for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung) OR at least 10 mm by spiral CT scan or MRI
  • Nonmeasurable lesions, including the following:
  • Small lesions
  • Bone lesions
  • Pleural or pericardial effusions
  • Ascites
  • Irradiated lesions, unless progression is documented after radiotherapy
  • Progressive or recurrent disease meeting at least 1 of the following criteria:
  • Measurable progressive disease
  • Biopsy-proven residual disease
  • Persistently elevated or rising ß-human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) titers with no other clear cause for elevation
  • Previously treated with 1 and only 1 regimen comprising etoposide and cisplatin with or without bleomycin AND exhibits clinical resistance by at least 1 of the following conditions after therapy\*:
  • Progressive GCT after a partial response to first-line therapy
  • Relapse after complete response (CR) to first-line therapy, including partial response (PR) surgically converted to CR
  • Second testicular primary with evidence of metastases after first-line therapy
  • Relapse after adjuvant chemotherapy NOTE: \*Patients failing to achieve PR or CR with first-line therapy as evidenced by rising markers or new disease within 4 weeks of first-line therapy are not eligible
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Not specified
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL (transfusion allowed)
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal\* (ULN)
  • AST and ALT ≤ 2.5 times ULN\* NOTE: \*Unless hepatic metastases are present
  • Renal
  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 50 mL/min
  • Other
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior dose-intensive therapy with stem cell replacement
  • Chemotherapy
  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy
  • No prior paclitaxel
  • No prior docetaxel
  • No prior ifosfamide
  • No other concurrent chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy
  • Concurrent or sequential radiotherapy to brain metastases allowed
  • No other concurrent palliative radiotherapy
  • Surgery
  • See Disease Characteristics
  • Concurrent surgery for brain metastases allowed
  • Other
  • Recovered from prior therapy

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2005

    Estimated Enrollment :

    1 Patients enrolled

    Trial Details

    Trial ID

    NCT00072215

    Start Date

    April 1 2004

    End Date

    April 1 2005

    Last Update

    July 4 2016

    Active Locations (79)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 20 (79 locations)

    1

    Northeast Alabama Regional Medical Center

    Anniston, Alabama, United States, 36207

    2

    Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, United States, 92093-0658

    3

    Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, United States, 90048

    4

    Naval Medical Center - San Diego

    San Diego, California, United States, 92134-3202