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Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin



Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin

For Condition: recurrent testicular cancer,recurrent ovarian germ cell tumor
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
Synopsis: 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 I/II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, cisplatin, and ifosfamide in treating patients who have ovarian or testicular germ cell tumors that are refractory to platinum -containing chemotherapy.
Details: OBJECTIVES: I. Determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and ifosfamide in patients with germ cell tumors with favorable prognostic features and resistance to cisplatin. II. Determine the efficacy of this regimen as salvage therapy in these patients. PROTOCOL OUTLINE: This is a dose escalation study of paclitaxel. Patients receive paclitaxel IV continuously on day 1 and cisplatin IV over 20 minutes and ifosfamide IV over 30 minutes on days 2-6. Filgrastim (G-CSF) is administered subcutaneously (SC) on days 7-18 or until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. Additional patients receive paclitaxel at the MTD. After completion of chemotherapy, some patients may undergo resection of residual masses. PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 2 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven germ cell tumor that is resistant to a platinum-based chemotherapy regimen - Active disease meeting 1 of the following conditions: Measurable or evaluable disease; Elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin); Unresectable residual disease after postchemotherapy surgery - Favorable prognostic factors for achieving a complete response (CR) to cisplatin-based salvage therapy required, including all of the following: No more than 1 prior regimen or 6 prior courses of cisplatin; Testis or ovarian germ cell primary site; Prior CR to cisplatin therapy; Incomplete response to first-line therapy that was based on either carboplatin or a suboptimal regimen of cisplatin --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; No prior paclitaxel or ifosfamide; At least 3 weeks since prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: See Disease Characteristics; Recovered from recent surgery --Patient Characteristics-- - Age: 15 and over - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 8.0 g/dL - Hepatic: Not specified - Renal: Creatinine clearance greater than 50 mL/min; Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator - Cardiovascular: If history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry - Other: No active infection not well controlled on antibiotics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RobertMotzer,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  CDR0000063452;  MSKCC-94012,NCI-V94-0408
Study Start Date: January 1994
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002559

Other Recurrent Ovarian Germ Cell Tumor Studies:
1. Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors

2. Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer

3. Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin

4. Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin

5. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors

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Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin
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