BEP Chemotherapy for Germ Cell Cancer
(P3BEP Trial)
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.12345Why 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.678910
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either accelerated or standard BEP chemotherapy for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Sydney
Lead Sponsor
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborator
Cambridge University Hospitals NHS Foundation Trust
Collaborator
Cancer Trials Ireland
Collaborator
Children's Oncology Group
Collaborator
Dana-Farber Cancer Institute
Collaborator
University of Southern California
Collaborator
Citations
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% ...
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 ...
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 ...
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).
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 ...
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% ...
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 ...
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 ...
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 ...
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.
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