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	Treatment or Intervention	Phase
recurrent testicular cancer recurrent ovarian germ cell tumor stage IV ovarian germ cell tumor stage III testicular cancer	Drug: gemcitabine  Drug: paclitaxel	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  15 Years and above

Criteria

PROTOCOL ENTRY 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)

--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

--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

Colorado
      CCOP - Colorado Cancer Research Program, Inc., Denver,  Colorado,  80209-5031,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611,  United States
      Veterans Affairs Medical Center - Chicago (Lakeside), Chicago,  Illinois,  60611,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States
      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
New Jersey
      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
New York
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Pennsylvania
      Hahnemann University Hospital, Philadelphia,  Pennsylvania,  19102-1192,  United States
Wisconsin
      CCOP - Marshfield Medical Research and Education Foundation, Marshfield,  Wisconsin,  54449,  United States
South Africa
      Pretoria Academic Hospital, Pretoria,  0001,  South Africa

Study chairs or principal investigators

Lawrence H. Einhorn,  Study Chair,  Eastern Cooperative Oncology Group   

Study ID Numbers:  CDR0000066562; E-9897
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003518
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08