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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 below

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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:

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I have had chemotherapy before.

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I am younger than 16 years old.

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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

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

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 • NCT02006667

46%

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

Non-cardiac chest pain

Alkaline phosphatase increased

Peripheral sensory neuropathy

Infections and infestations-others

Bone pain

Sinus bradycardia

Eyelid function disorder

General disorders and administration site conditions-other

Diarrhea

Bronchial infection

Nail infection

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

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