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| ID | Type | Description | Link |
|---|---|---|---|
| E9897 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | |||
| paclitaxel | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence H. Einhorn, MD | Indiana University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | 80209-5031 | United States | ||
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17290059 | Result | Einhorn LH, Brames MJ, Juliar B, Williams SD. Phase II study of paclitaxel plus gemcitabine salvage chemotherapy for germ cell tumors after progression following high-dose chemotherapy with tandem transplant. J Clin Oncol. 2007 Feb 10;25(5):513-6. doi: 10.1200/JCO.2006.07.7271. | |
| 11919245 | Result | Hinton S, Catalano P, Einhorn LH, Loehrer PJ Sr, Kuzel T, Vaughn D, Wilding G. Phase II study of paclitaxel plus gemcitabine in refractory germ cell tumors (E9897): a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2002 Apr 1;20(7):1859-63. doi: 10.1200/JCO.2002.07.158. |
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| Chicago |
| Illinois |
| 60611 |
| United States |
| Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago | Illinois | 60611 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5265 | United States |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | 46202 | United States |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Kimball Medical Center | Lakewood | New Jersey | 08701 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962-1956 | United States |
| University of Rochester Cancer Center | Rochester | New York | 14642 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102-1192 | United States |
| CCOP - Marshfield Medical Research and Education Foundation | Marshfield | Wisconsin | 54449 | United States |
| Pretoria Academic Hospital | Pretoria | 0001 | South Africa |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| C563236 | Testicular Germ Cell Tumor |
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D013733 | Testicular Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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