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

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ClinicalTrials.gov Identifier: NCT00072215
Recruitment Status : Terminated (poor accrual)
First Posted : November 6, 2003
Last Update Posted : July 4, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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 known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors.

PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors.


Condition or disease Intervention/treatment Phase
Extragonadal Germ Cell Tumor Testicular Germ Cell Tumor Drug: cisplatin Drug: ifosfamide Drug: paclitaxel Drug: vinblastine Phase 3

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 cisplatin as second-line therapy.

Secondary

  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the toxicity profiles of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior complete response or partial response with negative markers for at least 6 months (yes vs no) and relapse at least 2 years after completing first-line chemotherapy for germ cell tumors (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 20-30 minutes and ifosfamide IV over 30 minutes on days 2-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 7-18 OR pegfilgrastim SC once within 24-72 hours after completion of chemotherapy.
  • Arm II: Patients receive vinblastine IV on days 1 and 2 and cisplatin IV over 20-30 minutes and ifosfamide IV over 30 minutes on days 1-5. Patients also receive G-CSF SC on days 7-18 OR pegfilgrastim as in arm I.

In both arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Paclitaxel, Ifosfamide and Cisplatin Versus Vinblastine, Ifosfamide and Cisplatin as Second-Line Therapy for Patients With Relapsed/Resistant Germ Cell Tumors
Study Start Date : April 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005


Arm Intervention/treatment
Experimental: Regimen A: TIP Drug: cisplatin
given IV

Drug: ifosfamide
given IV

Drug: paclitaxel
given IV

Experimental: Regimen B: VeIP Drug: cisplatin
given IV

Drug: ifosfamide
given IV

Drug: vinblastine
given IV




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072215


  Show 79 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Robert J. Motzer, MD Memorial Sloan Kettering Cancer Center

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00072215     History of Changes
Other Study ID Numbers: CALGB-90106
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000339340 ( Registry Identifier: NCI Physician Data Query )
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and seminoma
testicular choriocarcinoma and teratoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma
testicular embryonal carcinoma and seminoma
testicular embryonal carcinoma and teratoma with seminoma
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and yolk sac tumor with seminoma
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma
testicular seminoma
testicular yolk sac tumor and teratoma with seminoma
testicular yolk sac tumor and teratoma
testicular yolk sac tumor
recurrent extragonadal non-seminomatous germ cell tumor
recurrent extragonadal seminoma
stage IV extragonadal non-seminomatous germ cell tumor
stage IV extragonadal seminoma
testicular immature teratoma
testicular mature teratoma
recurrent extragonadal germ cell tumor

Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Paclitaxel
Vinblastine
Albumin-Bound Paclitaxel
Cisplatin
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents