Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin
PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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 PATIENT CHARACTERISTICS: Age: * 15 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * 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 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
References
Publications (0)
Data not yet available