Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
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| ClinicalTrials.gov Identifier: NCT00003518 |
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Recruitment Status :
Completed
First Posted : May 24, 2004
Last Update Posted : January 27, 2010
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus gemcitabine in treating patients with refractory metastatic germ cell tumors that have not responded to surgery or chemotherapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Cancer Testicular Germ Cell Tumor | Drug: gemcitabine hydrochloride Drug: paclitaxel | Phase 2 |
OBJECTIVES: I. Evaluate the effect of gemcitabine plus paclitaxel on response rate, duration of remission, and survival in patients with refractory germ cell tumors. II. Evaluate the toxic effects of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1, 8, and 15 of each 4 week course. Treatment is repeated for a maximum of six courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 44 patients will be accrued over 19 months for this study.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 44 participants |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Paclitaxel Plus Gemcitabine in Refractory Germ Cell Tumors |
| Study Start Date : | January 1999 |
| Actual Primary Completion Date : | July 2002 |
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| Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or serologically confirmed metastatic germ cell neoplasm (gonadal or extragonadal primary) that cannot be cured with either surgery or chemotherapy Seminomas, nonseminomas, or ovarian germ cell tumors allowed If histologically confirmed, requires one or more of the following: Metastatic lesions on chest x-ray or CT scan Rising serum HCG or AFP If only evidence of progressive disease, then two additional consecutive determinations must exhibit serologic progression Only eligible if alternative causes for increased serum levels are absent Failed initial cisplatin combination chemotherapy (generally bleomycin/etoposide/cisplatin, cisplatin/etoposide, cisplatin/vinblastine, or similar regimens) Failed and demonstrated progressive disease following the administration of at least one "salvage" regimen for advanced germ cell neoplasms Failed no more than three prior regimens defined as: 25% increase in the product of perpendicular diameters of measurable tumor masses during prior therapy, new lesions OR Increasing AFP or HCG Disease progression during initial induction chemotherapy or with primary mediastinal nonseminomatous germ cell tumors can be treated with paclitaxel plus gemcitabine as second-line therapy (initial salvage chemotherapy)
PATIENT CHARACTERISTICS: Age: 15 and over Performance status: ECOG 0-2 Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 4 times normal Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: No active uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since major surgery and recovered Other: At least 1 week since prior intravenous antibiotics No concurrent intravenous antibiotics
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): NCT00003518
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| Study Chair: | Lawrence H. Einhorn, MD | Indiana University Melvin and Bren Simon Cancer Center |
| Responsible Party: | Group Chair, Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003518 |
| Other Study ID Numbers: |
CDR0000066562 E9897 |
| First Posted: | May 24, 2004 Key Record Dates |
| Last Update Posted: | January 27, 2010 |
| Last Verified: | January 2010 |
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stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor stage IV ovarian germ cell tumor recurrent ovarian germ cell tumor |
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Neoplasms, Germ Cell and Embryonal Testicular Neoplasms Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Genital Neoplasms, Male Testicular Diseases Gemcitabine Paclitaxel Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |