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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years from randomization

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

My cancer is in an advanced stage, affecting the area around my heart or other organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years from randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival Rate After 1 Course of Treatment

Secondary outcome measures

Overall Survival

Side effects data

From 2010 Phase 2 trial • 13 Patients • NCT02006667

46%

Platelet count decreased

38%

Nausea

23%

Fatigue

23%

Vomiting

23%

Chills

23%

White blood cell decreased

23%

Dyspnea

15%

Urinary tract infection

15%

Creatinine increased

15%

Anemia

15%

Weight loss

15%

Investigations-other

15%

Back pain

15%

Paresthesia

15%

Epistaxis

Nail infection

Bronchial infection

Peripheral sensory neuropathy

Bone pain

Alkaline phosphatase increased

Sinus bradycardia

Non-cardiac chest pain

Eyelid function disorder

General disorders and administration site conditions-other

Infections and infestations-others

Diarrhea

Fever

Upper respiratory infection

Confusion

Tachyarrhythmia

Gastrointestinal hermorrhage

Ileus

General disorders-other

Catheter related infection

Hematuria

Urinary tract obstruction

Pleural effusion

Vertigo

Endocrine disorders-other

Neutrophil count decreased

Arthralgia

Pain in extremity

Neck pain

Generalized muscle weakness

Neoplasms benign, malignant and unspecified-others

Depression

Alopecia

Nail ridging

Surgical and medical procedures-others

Chill

Gastrointestinal hemorrhage

Arthritis

Pain

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab/Gemcitabine/Cisplatin

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

1999

Completed Phase 3

~2740

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNICANCERLead Sponsor

221 Previous Clinical Trials

282,623 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main indication for cisplatin?

"cisplatin is a medication with potential efficacy in the treatment of various cancers, such as merkel cell cancer, squamous cell carcinoma, testicular choriocarcinoma, and locally advanced non-small cell lung cancer."

Answered by AI

How many patients are being given this treatment?

"As of May 11th, 2022, this study is no longer recruiting patients. It was first made public on November 26th, 2003. However, there are 2485 other trials searching for patients with teratoma and 1907 trials searching for patients that have received cisplatin."

Answered by AI

Is this study available to patients who are of age?

"The age limit for participants in this trial are those that are 16 years old or younger, and seniors that are 120 years old or younger."

Answered by AI

Have there been other tests done with cisplatin before?

"Cisplatin is a popular drug for clinical trials, with 1907 ongoing trials and 600 in Phase 3. The majority of clinical trials for cisplatin are in Guangzhou, Guangdong, but there are 97,044 locations running studies for cisplatin."

Answered by AI

Are there any medical or physical prerequisites to joining this clinical study?

"This study is recruiting individuals that have been diagnosed with teratoma and are between the ages of 16-120. As of now, there are 263 people that the study needs to enroll."

Answered by AI

Are investigators enrolling new patients in this clinical trial at this time?

"This specific clinical trial is not recruiting patients currently, according to the latest update from the study organizers on May 11th, 2022. However, there are 2485 other trials related to teratoma and 1907 trials exploring cisplatin that are actively looking for patients."

Answered by AI

Did the Food and Drug Administration give the okay to cisplatin?

"Cisplatin received a score of 3 because, as a Phase 3 trial drug, there is both evidence of its efficacy and multiple rounds of data affirming its safety."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Personalised Chemotherapy Based on Tumour Marker Decline in Poor Prognosis Germ-cell Tumours (GETUG 13): A Phase 3, Multicentre, Randomised Trial

Fizazi, Karim, Lance Pagliaro, Agnes Laplanche, Aude Fléchon, Josef Mardiak, Lionnel Geoffrois, Pierre Kerbrat, et al.. 2014. “Personalised Chemotherapy Based on Tumour Marker Decline in Poor Prognosis Germ-cell Tumours (GETUG 13): A Phase 3, Multicentre, Randomised Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(14)70490-5.

clinicaltrials.govStudy

Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

2003. "Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00104676.

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