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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003518
• Other study ID #: CDR0000066562
• Secondary ID: E9897
• Status: Completed
• Phase: Phase 2
• Start date: January 25, 1999

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Ovarian Cancer
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• paclitaxel

Locations

Country	Name	City	State
South Africa	Pretoria Academic Hospital	Pretoria
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago (Lakeside)	Chicago	Illinois
United States	Ireland Cancer Center	Cleveland	Ohio
United States	CCOP - Colorado Cancer Research Program, Inc.	Denver	Colorado
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	Kimball Medical Center	Lakewood	New Jersey
United States	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	University of Rochester Cancer Center	Rochester	New York
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Carle Cancer Center	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  South Africa, 

References & Publications (2)

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 — View Citation

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. — View Citation