BEP Chemotherapy for Germ Cell Cancer

(P3BEP Trial)

Recruiting at 24 trial locations

Overseen By P3BEP Trial Coordinator

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Sydney

Disqualifiers: Other malignancy, Cardiac disease, Respiratory disease, Neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether accelerating BEP chemotherapy treatment is more effective than the standard pace for treating metastatic germ cell cancer. The study evaluates three drugs: Bleomycin, Cisplatin, and Etoposide, administered in different schedules to determine which is more effective for patients with intermediate or poor-risk germ cell tumors. Males diagnosed with these specific types of germ cell tumors, particularly those with a high tumor burden needing prompt treatment, might find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that bleomycin, a key component of BEP chemotherapy, produced positive results in over 84% of patients with germ cell tumors. However, bleomycin can cause lung problems, though research indicates these do not significantly impact long-term survival.

Cisplatin, another drug in the treatment, is widely used for various cancers, including testicular cancer. It is highly effective, but there is a risk of developing new tumors, which should be considered.

Etoposide, the third drug in the treatment plan, has successfully treated testicular cancer and other cancer types. It has helped many patients remain disease-free.

These drugs are well-known in cancer treatment. While they can have serious side effects, their safety is well-established, especially since they are approved for treating other cancers. This suggests a level of safety, although individual experiences with side effects can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BEP chemotherapy for germ cell cancer because it offers a potentially more efficient and tailored approach for patients. Unlike other treatments, the accelerated BEP regimen shortens each cycle to just two weeks, potentially reducing the overall treatment time while maintaining effectiveness. This accelerated schedule includes fewer doses of bleomycin per cycle, which may lessen some side effects. Additionally, the treatment is personalized, with the bleomycin dose adjusted based on the patient's body surface area, allowing for a more individualized and potentially safer treatment experience.

What evidence suggests that this trial's treatments could be effective for germ cell cancer?

This trial will compare two treatment arms: Standard BEP and Accelerated BEP chemotherapy. Both involve combinations of three drugs—bleomycin, etoposide, and cisplatin—effective for treating germ cell tumors. Studies have shown impressive 5-year survival rates with BEP: 92% for patients with a poor outlook and 94% for those with a moderate outlook. Specifically, Accelerated BEP, one of the trial arms, has shown promising results, with many patients completing the treatment successfully. BEP is widely recognized as a standard treatment for these cancers due to these strong survival rates. This evidence suggests that BEP chemotherapy could be a powerful option for those with advanced germ cell tumors. ^{6 7 8 9 10}

Who Is on the Research Team?

Peter Grimison

Principal Investigator

Chris O'Brien Lifehouse

Are You a Good Fit for This Trial?

This trial is for males aged 11-45 with intermediate to poor-risk metastatic germ cell tumors, including non-seminoma or seminoma. Participants must have certain levels of tumor markers and adequate organ function. It's not suitable for those outside the age range or with conditions that don't meet the specific criteria outlined.

Inclusion Criteria

My cancer has spread or started outside the testicles.

Your cancer is classified as intermediate or poor prognosis according to a specific system called IGCCC. The criteria for this classification can be found in the study protocol.

I am between 11 and 45 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either accelerated or standard BEP chemotherapy for 12 weeks

12 weeks

Weekly visits for chemotherapy administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Regular follow-up visits

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Bleomycin Sulfate
• Cisplatin
• Etoposide
• Filgrastim
• Pegfilgrastim

Trial Overview The study compares accelerated BEP chemotherapy against standard BEP chemotherapy in treating germ cell tumors. BEP includes Bleomycin Sulfate, Etoposide, and Cisplatin drugs; Pegfilgrastim or Filgrastim may also be used to support white blood cell growth.

How Is the Trial Designed?

Group I: Experimental Arm - Accelerated BEP Experimental Treatment 5 Interventions

Participants 16years or older will receive 4 cycles of Accelerated BEP as follows: * Bleomycin 30,000 IU IV wkly for 2 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1- 5 * Pegylated G-CSF 6 mg SCI on day 6 Patients \<16years and weighs ≥45 kg will receive: * Bleomycin \*15,000 - 30,000 IU IV wkly for 2 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1 - 5 * Pegylated G-CSF 6 mg SCI on day 6 Patients \<16years and weighs \<45 kg will receive: * Bleomycin \*15,000 - 30,000 IU IV wkly for 2 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1 - 5 * Filgrastim 10mcg/kg/day on day 6, until ANC ≥1 x10\^9/ L Each cycle is 2 weeks (14days) Following 4xBEP cycles, patients will receive additional bleomycin as follows: \- Bleomycin \*15,000 - 30,000 IU IV wkly for 4 doses \* The dose of bleomycin is decided by the treating physician and based on the patient's BSA. The planned total duration is 12 weeks.

Group II: Standard Arm - Standard BEP Active Control 5 Interventions

Participants 16 years or older will receive 4 cycles of Standard BEP as follows: * Bleomycin 30,000 IU IV weekly for 3 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1 - 5 * Pegylated G-CSF 6 mg SCI on day 6 Patients \< 16 years old and weighs ≥ 45 kg will receive: * Bleomycin \*15,000 - 30,000 IU IV weekly for 3 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1 - 5 * Pegylated G-CSF 6 mg SCI on day 6 Patients \<16 years old and weighs \< 45 kg will receive: * Bleomycin \*15,000 - 30,000 IU IV weekly for 3 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1 - 5 * Filgrastim 10mcg/kg/day on day 6, until post-nadir Absolute Neutrophil Count ≥1 x10\^9/ L * The dose of bleomycin is decided by the treating physician and based on the patient's Body Surface Area. Each cycle is 3 weeks (21 days). The planned total duration of treatment is 12 weeks.

Who Is Running the Clinical Trial?

University of Sydney

Lead Sponsor

Trials

208

Recruited

417,000+

Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Collaborator

Trials

21

Recruited

7,000+

Cambridge University Hospitals NHS Foundation Trust

Collaborator

Trials

280

Recruited

501,000+

Cancer Trials Ireland

Collaborator

Trials

85

Recruited

25,600+

Children's Oncology Group

Collaborator

Trials

467

Recruited

241,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7045084/

A randomised phase II trial (ISRCTN53643604) Intensive induction chemotherapy met response targets in poor prognosis germ cell tumours. Three-year progression-free survival was 56% for CBOP/BEP and 39% ...

2. asco.org asco.org/abstracts-presentations/ABSTRACT165751

Long-term outcomes of accelerated BEP (bleomycin ... 5-year overall survival was 92% (95% CI: 54%-99%) for poor-prognosis, 94% (95% CI: 63%-99%) for intermediate-prognosis and 100% (95% CI: NA) for good-prognosis ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)36533-0/fulltext

Long-term outcomes of accelerated BEP (bleomycin ... The primary end point of feasibility was met, with 86% of patients able to complete the etoposide and cisplatin components of BEP and be eligible to receive a ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0959804914010053

Outcome of 3-day bleomycin, etoposide and cisplatin ... The combination of bleomycin, etoposide and cisplatin (BEP) is currently the most widely used treatment for malignant ovarian germ cell tumours (MOGCTs).

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2016.34.15_suppl.e16056

Long-term outcomes of accelerated BEP (bleomycin ... Long-term outcomes of accelerated BEP (bleomycin, etoposide, cisplatin) for advanced germ cell tumors: updated analysis of an Australian ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004817/

Efficacy and safety of modified bleomycin administration ... Favorable responses, including complete remission and partial response with negative tumor markers, were achieved in 91.07% of good-risk, 84.13% ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29700638/

Prognostic impact of bleomycin pulmonary toxicity on the ... Kaplan-Meier analysis revealed that the presence of BPT had no significant impact on either 5-year overall survival or progression-free survival ...

8. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT03067181

UCSF Germ Cell Tumor Trial → Active Surveillance ... This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00324298

Bleomycin, Etoposide, and Cisplatin in Treating Patients ... PURPOSE: This randomized phase III trial is studying two different schedules of bleomycin to compare how well they work when given together with ...

10. asco.org asco.org/abstracts-presentations/ABSTRACT437036

Safety of pegfilgrastim in patients with metastatic germ-cell ... 79% of patients included had nonseminomatous germ-cell tumor (NSGCT). IGCCCG risk was good in 146, intermediate in 19, and poor in 31 patients.