Clinical Trials Logo

Clinical Trial Summary

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. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.

PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.


Clinical Trial Description

OBJECTIVES:

Phase II

- Compare the complete response rates in men with intermediate prognosis germ cell cancer treated with bleomycin, cisplatin, and etoposide (BEP) vs bleomycin, cisplatin, etoposide, and paclitaxel (T-BEP).

- Define the toxicity profile of T-BEP in these patients.

Phase III

- Compare the disease-free survival of patients treated with these regimens.

- Compare the complete response rates and overall survival of patients treated with these regimens.

- Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens.

- Compare the acute and intermediate (1-2 years) side effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (seminoma vs non-seminoma) and hospital. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cisplatin IV and etoposide IV on days 1-5 and bleomycin IV on days 1, 8, and 15.

- Arm II: Patients receive cisplatin, etoposide, and bleomycin as in arm I and paclitaxel IV over 3 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 6-15.

In both arms, treatment repeats every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before treatment randomization and at 1 and 2 years after randomization.

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 84-164 patients (42-82 per treatment arm) will be accrued for the phase II study. A total of 498 patients (249 per treatment arm) will be accrued for the phase III study. Accrual will be completed within 4 years. ;


Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00003643
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date October 1998

See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Withdrawn NCT00006126 - Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery Phase 1
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Completed NCT00002596 - Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors Phase 3
Not yet recruiting NCT03448822 - Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
Completed NCT01433224 - Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression N/A
Recruiting NCT01172912 - High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy Phase 2
Completed NCT00293384 - Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant N/A
Completed NCT00019331 - Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors Phase 2
Completed NCT00003107 - Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors Phase 1
Completed NCT00002515 - Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer Phase 2
Recruiting NCT06133699 - Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors N/A
Recruiting NCT05670938 - Follow-up After Surgery for Testicular Cancer
Active, not recruiting NCT00104676 - Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors Phase 3
Recruiting NCT00551122 - Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors Phase 1/Phase 2
Completed NCT00002508 - Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors Phase 1/Phase 2
Completed NCT00003800 - Diagnostic Study of Patients With Stage I Testicular Cancer N/A
Terminated NCT05012397 - Milademetan in Advanced/Metastatic Solid Tumors Phase 2
Completed NCT00007813 - Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors Phase 1
Terminated NCT00324324 - Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant Phase 3