Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, ifosfamide, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with paclitaxel, ifosfamide, and cisplatin, and to see how well they work in treating patients with progressive or relapsed metastatic germ cell tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southampton
• Collaborator: University Hospital Southampton NHS Foundation Trust
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Gemcitabine; Ifosfamide; Isophosphamide mustard; Lenograstim; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Meets the following criteria:

• Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma

• Unresectable metastatic disease

• No completely resected cancer

• Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer

• In first relapse after a single prior cisplatin-containing combination chemotherapy

• Patients with late relapse (i.e., > 2 years post initial chemotherapy) should be considered for surgery rather than chemotherapy, if technically feasible

• No patients with cerebral metastases alone

• Progressive cerebral and systemic disease may be considered for this study, provided cranial irradiation is also considered as a component of care

PATIENT CHARACTERISTICS:

• Medically and psychologically fit to receive this intensive chemotherapy schedule

• WBC > 3.5 times 10^9/L

• Platelet count > 130 times 10^9/L

• Glomerular filtration rate ≥ 50 mL/min (as determined by 24 hour creatinine clearance or nuclear medicine technique)

• Fertile patients must use effective contraception

• No other prior malignancy except successfully treated nonmelanoma skin cancer or superficial bladder cancer

• No prior allergic reactions to cisplatin or other platinum compounds

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics