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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072215 |
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: filgrastim Drug: ifosfamide Drug: paclitaxel Drug: pegfilgrastim Drug: vinblastine |
Phase III |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Ifosfamide Filgrastim Cisplatin Paclitaxel Pegfilgrastim Vinblastine Vinblastine sulfate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed germ cell tumor (GCT), including 1 of the following primary tumor sites:
Seminoma
Nonseminoma
Other extragonadal site
Must have evidence of metastatic disease, including either of the following:
Unidimensionally measurable lesions
Nonmeasurable lesions, including the following:
Progressive or recurrent disease meeting at least 1 of the following criteria:
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*:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations![]() |
Show 79 Study Locations |
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Robert J. Motzer, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000339340, CALGB-90106 |
| First Received: | November 4, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00072215 |
| Health Authority: | United States: Federal Government |
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