Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
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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 |
- 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 |
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
Show 79 Study Locations| 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