Clinical trial NCT00324298: Bleomycin, Etoposide, and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles
Official title: A Randomized Phase III Toxicity Study of Day 2, 3, 8, 15 Short (30 Minute) Versus Day 1, 2, 3 Long (72 Hours) Infusion Bleomycin for Patients With IGCCCG Good Prognosis Germ Cell Tumors, TE3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Drug/Agent Toxicity by Tissue/Organ
Testicular Germ Cell Tumor
Keywords: drug/agent toxicity by tissue/organ
stage III malignant testicular germ cell tumor
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-05-11
Enrollment: 210
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of bleomycin is more effective when given together with etoposide and cisplatin in treating metastatic germ cell cancer of the testicles.

PURPOSE: This randomized phase III trial is studying two different schedules of bleomycin to compare how well they work when given together with etoposide and cisplatin in treating patients with metastatic germ cell cancer of the testicles.

Detailed description: OBJECTIVES:

Primary

* Determine if long-infusion schedule of bleomycin is less toxic to the lungs than short-infusion schedule of bleomycin in patients who are undergoing combination chemotherapy comprising bleomycin, etoposide, and cisplatin for good-prognosis, metastatic germ cell cancer of the testes.
* Determine if early lung function tests are a predictor for late toxicity.
* Determine if any indication of enhanced response to the long-infusion schedule justifies a large-scale phase III evaluation.
* Validate the O'Sullivan et al prognostic scoring system for bleomycin toxicity.

Secondary

* Determine response to treatment.
* Determine progression-free survival and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≤ 30 years vs \> 30 years), current smoker or has smoked within the past 1 year (yes vs no), and creatinine clearance (≤ 80 mL/min vs \> 80 mL/min). Patients are randomized to 1 of 2 treatment arms.

* Arm I (short-infusion schedule of bleomycin): Patients receive etoposide IV over 2 hours on days 1-3, cisplatin IV over 4 hours on days 1 and 2, and bleomycin IV over 30 minutes on days 2, 8, and 15.
* Arm II (long-infusion schedule of bleomycin): Patients receive etoposide and cisplatin as in arm I. Patients also receive bleomycin IV continuously over 72 hours on days 1-3.

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

After completion of study treatment, patients are followed at 4 weeks and then every 3 months for 24 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of metastatic germ cell cancer of the testes

  * Good-prognosis disease
* Eligible for treatment with bleomycin, etoposide, and cisplatin

PATIENT CHARACTERISTICS:

* Creatinine clearance ≥ 60 mL/min
* No other prior or concurrent malignancy except basal cell skin cancer
* No other major systemic illness
* No impaired respiratory function, including any of the following:

  * Shortness of breath on minimal exertion
  * Hypoxia at rest
* Carbon monoxide transfer, total lung capacity, and FEV_1 \> 60% of predicted

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy

Primary outcomes:
measure: Pulmonary toxicity
Secondary outcomes:
measure: Response to treatment
measure: Progression-free survival
measure: Overall survival
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: Colchester
country: United Kingdom
facility: Essex County Hospital
state: England
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: University College of London Hospitals
state: England
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
state: England
Study officials:
affiliation: St. Bartholomew's Hospital
name: Jonathan Shamash, MD, FRCP
role: STUDY_CHAIR
References: