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

Phase 2
15 Years
Not Enrolling
Ovarian Cancer, Testicular Germ Cell Tumor

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Trial Information

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Lawrence H. Einhorn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 1999

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • stage III malignant testicular germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • Ovarian Neoplasms
  • Neoplasms, Germ Cell and Embryonal



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Rochester Cancer Center Rochester, New York  14642
Ireland Cancer Center Cleveland, Ohio  44106-5065
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
CCOP - Colorado Cancer Research Program, Inc. Denver, Colorado  80209-5031
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
CCOP - Marshfield Medical Research and Education Foundation Marshfield, Wisconsin  54449
Veterans Affairs Medical Center - Chicago (Lakeside) Chicago, Illinois  60611
Hackensack University Medical Center Hackensack, New Jersey  07601
Kimball Medical Center Lakewood, New Jersey  08701