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

This study has been terminated.
(poor accrual)
Sponsor:
Collaborator:
Information provided by:
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00072215
First received: November 4, 2003
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Extragonadal Germ Cell Tumor
Testicular Germ Cell Tumor
Drug: cisplatin
Drug: ifosfamide
Drug: paclitaxel
Drug: vinblastine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: April 2004
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

PROJECTED ACCRUAL: A total of 470 patients (235 per treatment arm) will be accrued for this study within 5.5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072215

  Show 79 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00072215     History of Changes
Other Study ID Numbers: CDR0000339340, U10CA031946, CALGB-90106
Study First Received: November 4, 2003
Last Updated: June 21, 2011
Health Authority: United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:
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:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Isophosphamide mustard
Cisplatin
Ifosfamide
Vinblastine
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 16, 2013