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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003518
Other study ID # CDR0000066562
Secondary ID E9897
Status Completed
Phase Phase 2
First received
Last updated
Start date January 25, 1999

Study information

Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
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. completion date
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

Study Design


Related Conditions & MeSH terms


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

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