Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003518

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

2.3

Patients Per Site

Study Details

Study Description

Brief Summary

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

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Primary Purpose:

Treatment

Official Title:

Phase II Study of Paclitaxel Plus Gemcitabine in Refractory Germ Cell Tumors

Study Start Date :

Jan 1, 1999

Actual Primary Completion Date :

Jul 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Colorado Cancer Research Program, Inc.	Denver	Colorado	United States	80209-5031
2	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611
3	Veterans Affairs Medical Center - Chicago (Lakeside)	Chicago	Illinois	United States	60611
4	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
5	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5265
6	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana	United States	46202
7	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
8	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
9	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
10	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
11	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
12	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
13	Kimball Medical Center	Lakewood	New Jersey	United States	08701
14	Morristown Memorial Hospital	Morristown	New Jersey	United States	07962-1956
15	University of Rochester Cancer Center	Rochester	New York	United States	14642
16	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
17	Hahnemann University Hospital	Philadelphia	Pennsylvania	United States	19102-1192
18	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin	United States	54449
19	Pretoria Academic Hospital	Pretoria		South Africa	0001