Cisplatin for Primary Peritoneal Serous Adenocarcinoma
Phase-Based Progress Estimates
Effectiveness
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Primary Peritoneal Serous Adenocarcinoma+42 More
Cisplatin - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery may kill more tumor cells compared to usual care.
Eligible Conditions
- Primary Peritoneal Serous Adenocarcinoma
- Stage IIIA Primary Peritoneal Cancer AJCC v8
- Fallopian Tube Carcinoma
- Stage IIIB Primary Peritoneal Cancer AJCC v8
- Primary Peritoneal Endometrioid Adenocarcinoma
- Stage III Ovarian Cancer AJCC v8
- Stage IIIC Primary Peritoneal Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Malignant neoplasm of ovary
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Ovarian Endometrioid Adenocarcinoma
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
- Fallopian Tubes
- Fallopian Tube Serous Adenocarcinoma
- Mucinous Adenocarcinoma
- Ovarian Mucinous Adenocarcinoma
- Ovarian Serous Adenocarcinoma
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IVB Primary Peritoneal Cancer AJCC v8
- Stage III Primary Peritoneal Cancer AJCC v8
Treatment Effectiveness
Effectiveness Progress
Other trials for Primary Peritoneal Serous Adenocarcinoma
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: For 3-5 years after study
Day 1
Feasibility of chemotherapy immediately perioperatively
Month 6
Quality of life (QOL) assessment EORTC QLQ-C30
Year 5
Recurrence free survival
Up to 1 year
Percentage of patients in Arm C with a treatment free interval of < 8 weeks
Tumor response
Day 30
Incidence of chemotherapy-related adverse events
Trial Safety
Safety Progress
Other trials for Primary Peritoneal Serous Adenocarcinoma
Trial Design
3 Treatment Groups
Arm I (carboplatin, paclitaxel, CRS)
1 of 3
Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin)
1 of 3
Arm III (carboplatin, paclitaxel, CRS, cisplatin)
1 of 3
Active Control
Experimental Treatment
45 Total Participants · 3 Treatment Groups
Primary Treatment: Cisplatin · No Placebo Group · Phase < 1
Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin)Experimental Group · 7 Interventions: Carboplatin, Cytoreductive Surgery, Cisplatin, Hyperthermic Intraperitoneal Chemotherapy, Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Drug, Procedure, Drug, Drug, Drug, Other, Other
Arm III (carboplatin, paclitaxel, CRS, cisplatin)Experimental Group · 6 Interventions: Carboplatin, Cytoreductive Surgery, Cisplatin, Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Drug, Procedure, Drug, Drug, Other, Other
Arm I (carboplatin, paclitaxel, CRS)ActiveComparator Group · 5 Interventions: Carboplatin, Cytoreductive Surgery, Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Drug, Procedure, Drug, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6570
Cytoreductive Surgery
2011
Completed Phase 1
~150
Cisplatin
2013
Completed Phase 3
~3340
Hyperthermic Intraperitoneal Chemotherapy
2010
Completed Phase 3
~190
Paclitaxel
2011
Completed Phase 4
~6340
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: for 3-5 years after study
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
2011First Recorded Clinical Trial
12 TrialsResearching Primary Peritoneal Serous Adenocarcinoma
203 CompletedClinical Trials
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
281 Previous Clinical Trials
285,773 Total Patients Enrolled
Floor Backes, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
5 Previous Clinical Trials
295 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:A primary tumor of the omentum or peritoneum with a size of 2 cm or more or regional lymph node metastasis.
Patient planned for or currently receiving neoadjuvant chemotherapy due to the fact that optimal primary CRS was determined not to be feasible by the primary surgeon.
You are able to understand (English-speaking) and are willing to sign a written, informed consent.
You have either a biopsy or a histology block from a cytology to demonstrate Mullerian origin.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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