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Antibiotics

Cisplatin for Germ Cell Tumors (P3BEP Trial)

Q: How can I become apart of this research project?

This study is looking for 500 people with germ cell tumors aged 11-45. The most important criteria that applicants should meet are as follows: have adequate renal function, be histologically or cytologically confirmed to have a germ cell tumor, have primary <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> arising in the testis, ovary, retro-peritoneum, or mediastinum, have metastatic disease or a non-testicular primary, show an intermediate or poor prognosis according to IGCCC classification3 ,have adequate bone marrow and liver function ,and finally have an ECOG Performance Status of 0, 1 , 2 ,or 3 .(For more information

Q: Are geriatric patients eligible for this experimental therapy?

As this trial has strict age limits for participation, only those aged 11-45 are able to take part.

Q: To your knowledge, what other research has been done with Cisplatin?

Currently, Cisplatin is being investigated in 1103 different active clinical trials- with 366 of these studies being Phase 3. The majority of these research programs are situated within Shanghai; however, there are 53491 total locations running trials for Cisplatin.

Q: Are researchers looking for new participants at this time?

That is correct, the information on clinicaltrials.gov says that this particular trial is still looking for volunteers. This experiment was first announced on February 1st, 2014 and has since been updated on November 25th, 2021. They are admitting a total of 500 people at one location.

Q: For what illness does Cisplatin usually provide symptom relief?

Cisplatin can ameliorate symptoms associated with skin irritation, <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>, and testicular choriocarcinoma.

Q: Could you remind me how many people are testing this new medication?

That is correct, the online information states that this clinical trial is still looking for patients. This particular study was first posted on February 1st, 2014 with the most recent update happening on November 25th, 2021. They are hoping to find 500 people total from a single location.

Q: Is it dangerous to use Cisplatin?

Cisplatin has received a score of 3 from our team at Power. This is because Phase 3 trials have shown some efficacy and there is supporting safety data from multiple rounds of testing.

Phase 3

Waitlist Available

Research Sponsored by University of Sydney

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomisation up to disease progression or date of death whichever come first, assessed up to 5 years

Awards & highlights

P3BEP Trial Summary

This trial will compare two types of chemotherapy to see which is more effective in treating men with metastatic germ cell tumours.

Eligible Conditions

Germ Cell Tumors

P3BEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomisation up to disease progression or date of death whichever come first, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomisation up to disease progression or date of death whichever come first, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomisation up to disease progression or date of death whichever come first, assessed up to 5 years 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 (disease progression or death)

Secondary outcome measures

Adverse events (worst grade according to NCI CTCAE v4.03)

Delivered dose-intensity of chemotherapy (relative to standard BEP)

Final response assessment

+5 more

Other outcome measures

Exploratory biomarker investigations

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

P3BEP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Arm - Accelerated BEPExperimental Treatment5 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 BEPActive Control5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etoposide

2010

Completed Phase 3

~2440

Cisplatin

2013

Completed Phase 3

~1940

Filgrastim

2000

Completed Phase 3

~3670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of SydneyLead Sponsor

190 Previous Clinical Trials

214,232 Total Patients Enrolled

Australian and New Zealand Urogenital and Prostate Cancer Trials GroupOTHER

18 Previous Clinical Trials

6,072 Total Patients Enrolled

Cambridge University Hospitals NHS Foundation TrustOTHER

266 Previous Clinical Trials

495,312 Total Patients Enrolled

Frequently Asked Questions

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

How can I become apart of this research project?

"This study is looking for 500 people with germ cell tumors aged 11-45. The most important criteria that applicants should meet are as follows: have adequate renal function, be histologically or cytologically confirmed to have a germ cell tumor, have primary cancer arising in the testis, ovary, retro-peritoneum, or mediastinum, have metastatic disease or a non-testicular primary, show an intermediate or poor prognosis according to IGCCC classification3 ,have adequate bone marrow and liver function ,and finally have an ECOG Performance Status of 0, 1 , 2 ,or 3 .(For more information"

Answered by AI

Are geriatric patients eligible for this experimental therapy?

"As this trial has strict age limits for participation, only those aged 11-45 are able to take part."

Answered by AI

To your knowledge, what other research has been done with Cisplatin?

"Currently, Cisplatin is being investigated in 1103 different active clinical trials- with 366 of these studies being Phase 3. The majority of these research programs are situated within Shanghai; however, there are 53491 total locations running trials for Cisplatin."

Answered by AI

Are researchers looking for new participants at this time?

"That is correct, the information on clinicaltrials.gov says that this particular trial is still looking for volunteers. This experiment was first announced on February 1st, 2014 and has since been updated on November 25th, 2021. They are admitting a total of 500 people at one location."

Answered by AI

For what illness does Cisplatin usually provide symptom relief?

"Cisplatin can ameliorate symptoms associated with skin irritation, squamous cell carcinoma, and testicular choriocarcinoma."

Answered by AI

Could you remind me how many people are testing this new medication?

"That is correct, the online information states that this clinical trial is still looking for patients. This particular study was first posted on February 1st, 2014 with the most recent update happening on November 25th, 2021. They are hoping to find 500 people total from a single location."

Answered by AI

Is it dangerous to use Cisplatin?

"Cisplatin has received a score of 3 from our team at Power. This is because Phase 3 trials have shown some efficacy and there is supporting safety data from multiple rounds of testing."

Answered by AI

Recent research and studies

BMC CancerJournal

Protocol for the P3BEP Trial (ANZUP 1302): An International Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Adult and Paediatric Male and Female Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumours

Lawrence, Nicola J., on behalf of ANZUP, Howard Chan, Guy Toner, Martin R. Stockler, Andrew Martin, Sonia Yip, et al.. 2018. “Protocol for the P3BEP Trial (ANZUP 1302): An International Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Adult and Paediatric Male and Female Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumours”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-018-4745-3.

clinicaltrials.govStudy

Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours

2014. "Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02582697.