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Anti-tumor antibiotic
Chemotherapy for Germ Cell Tumors
Phase 3
Waitlist Available
Research Sponsored by UNICANCER
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Poor prognosis disease meeting criteria of mediastinal primary site or non-pulmonary visceral metastases
Must not have
Prior chemotherapy
Age under 16
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years from randomization
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is comparing two different chemotherapy combinations to see which is more effective in treating patients with stage II or stage III non-seminomatous germ cell tumors.
Who is the study for?
This trial is for individuals over 16 with stage II or III non-seminomatous germ cell tumors, who haven't had chemotherapy before. They should have certain blood and organ function levels within specific ranges and no HIV. Prior basal cell skin cancer is okay.
What is being tested?
The study compares two combination chemotherapy regimens to see which one is more effective at stopping tumor growth in patients with advanced germ cell tumors. The drugs being tested include bleomycin sulfate, cisplatin, etoposide, ifosfamide, oxaliplatin, and paclitaxel.
What are the potential side effects?
Potential side effects of the chemotherapy drugs may include nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood counts, kidney damage from cisplatin and lung problems from bleomycin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is in an advanced stage, affecting the area around my heart or other organs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had chemotherapy before.
Select...
I am younger than 16 years old.
Select...
I have had cancer before, but it was not skin cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years from randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years from randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free Survival Rate After 1 Course of Treatment
Secondary study objectives
Overall Survival
Side effects data
From 2010 Phase 2 trial • 13 Patients • NCT0200666746%
Platelet count decreased
38%
Nausea
23%
Fatigue
23%
White blood cell decreased
23%
Vomiting
23%
Chills
23%
Dyspnea
15%
Creatinine increased
15%
Urinary tract infection
15%
Anemia
15%
Weight loss
15%
Investigations-other
15%
Back pain
15%
Paresthesia
15%
Epistaxis
8%
Non-cardiac chest pain
8%
Alkaline phosphatase increased
8%
Peripheral sensory neuropathy
8%
Infections and infestations-others
8%
Bone pain
8%
Sinus bradycardia
8%
Eyelid function disorder
8%
General disorders and administration site conditions-other
8%
Diarrhea
8%
Bronchial infection
8%
Nail infection
8%
Fever
8%
Upper respiratory infection
8%
Confusion
8%
Tachyarrhythmia
8%
Gastrointestinal hermorrhage
8%
Ileus
8%
General disorders-other
8%
Catheter related infection
8%
Hematuria
8%
Urinary tract obstruction
8%
Pleural effusion
8%
Vertigo
8%
Endocrine disorders-other
8%
Neutrophil count decreased
8%
Arthralgia
8%
Pain in extremity
8%
Neck pain
8%
Generalized muscle weakness
8%
Neoplasms benign, malignant and unspecified-others
8%
Depression
8%
Alopecia
8%
Nail ridging
8%
Surgical and medical procedures-others
8%
Chill
8%
Gastrointestinal hemorrhage
8%
Arthritis
8%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab/Gemcitabine/Cisplatin
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IIExperimental Treatment6 Interventions
Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.
Group II: Arm IActive Control3 Interventions
Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bleomycin sulfate
2008
Completed Phase 3
~3940
cisplatin
1997
Completed Phase 3
~3290
etoposide
1994
Completed Phase 3
~9300
ifosfamide
1999
Completed Phase 3
~2230
oxaliplatin
2002
Completed Phase 3
~6370
paclitaxel
1996
Completed Phase 3
~4310
Find a Location
Who is running the clinical trial?
UNICANCERLead Sponsor
233 Previous Clinical Trials
309,573 Total Patients Enrolled
1 Trials studying Teratoma
420 Patients Enrolled for Teratoma
Karim Fizazi, MD, PhDStudy ChairGustave Roussy, Cancer Campus, Grand Paris
3 Previous Clinical Trials
2,102 Total Patients Enrolled