Clinical trial · Interventional
Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
A Randomized Phase III Study of Paclitaxel, Ifosfamide and Cisplatin Versus Vinblastine, Ifosfamide and Cisplatin as Second-Line Therapy for Patients With Relapsed/Resistant Germ Cell Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors. PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors.
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 |
|---|---|---|---|
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen A: TIP
- interventionNames
- Drug: cisplatin
- Drug: ifosfamide
- Drug: paclitaxel
- type
- EXPERIMENTAL
- label
- Regimen B: VeIP
- interventionNames
- Drug: cisplatin
- Drug: ifosfamide
- Drug: vinblastine
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed germ cell tumor (GCT), including 1 of the following primary tumor sites:
* Seminoma
* Testis
* Retroperitoneum
* Mediastinum
* Other extragonadal site
* Nonseminoma
* Testis
* Retroperitoneum
* Other extragonadal site
* No tumor of the mediastinum
* Must have evidence of metastatic disease, including either of the following:
* Unidimensionally measurable lesions
* At least 20 mm by conventional techniques (e.g., physical exam for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung) OR at least 10 mm by spiral CT scan or MRI
* Nonmeasurable lesions, including the following:
* Small lesions
* Bone lesions
* Pleural or pericardial effusions
* Ascites
* Irradiated lesions, unless progression is documented after radiotherapy
* Progressive or recurrent disease meeting at least 1 of the following criteria:
* Measurable progressive disease
* Biopsy-proven residual disease
* Persistently elevated or rising ß-human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) titers with no other clear cause for elevation
* Previously treated with 1 and only 1 regimen comprising etoposide and cisplatin with or without bleomycin AND exhibits clinical resistance by at least 1 of the following conditions after therapy\*:
* Progressive GCT after a partial response to first-line therapy
* Relapse after complete response (CR) to first-line therapy, including partial response (PR) surgically converted to CR
* Second testicular primary with evidence of metastases after first-line therapy
* Relapse after adjuvant chemotherapy NOTE: \*Patients failing to achieve PR or CR with first-line therapy as evidenced by rising markers or new disease within 4 weeks of first-line therapy are not eligible
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL (transfusion allowed)
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal\* (ULN)
* AST and ALT ≤ 2.5 times ULN\* NOTE: \*Unless hepatic metastases are present
Renal
* Creatinine ≤ 1.5 times ULN OR
* Creatinine clearance ≥ 50 mL/min
Other
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior dose-intensive therapy with stem cell replacement
Chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy
* No prior paclitaxel
* No prior docetaxel
* No prior ifosfamide
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy
* Concurrent or sequential radiotherapy to brain metastases allowed
* No other concurrent palliative radiotherapy
Surgery
* See Disease Characteristics
* Concurrent surgery for brain metastases allowed
Other
* Recovered from prior therapyReferences
Publications (0)
Data not yet available