Cisplatin for Stage IIIC Uterine Corpus Cancer AJCC v7

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stage IIIC Uterine Corpus Cancer AJCC v7+36 More
Cisplatin - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing surgery with or without heated and unheated chemotherapy for ovarian, fallopian tube, uterine, or peritoneal cancer.

Eligible Conditions
  • Stage IIIC Uterine Corpus Cancer AJCC v7
  • Stage IV Primary Peritoneal Cancer AJCC v7
  • Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Malignant neoplasm of ovary
  • Stage IIIB Uterine Corpus Cancer AJCC v7
  • Stage III Ovarian Cancer AJCC v6 and v7
  • Stage III Primary Peritoneal Cancer AJCC v7
  • Stage IVA Uterine Corpus Cancer AJCC v7
  • Stage IIIB Primary Peritoneal Cancer AJCC v7
  • Stage IIIA Primary Peritoneal Cancer AJCC v7
  • Stage III Uterine Corpus Cancer AJCC v7
  • Stage IIIA Fallopian Tube Cancer AJCC v7
  • Stage IIIA Uterine Corpus Cancer AJCC v7
  • Stage IV Ovarian Cancer AJCC v6 and v7
  • Stage IVB Uterine Corpus Cancer AJCC v7
  • Stage IV Uterine Corpus Cancer AJCC v7
  • Recurrent Uterine Corpus Carcinoma
  • Stage IIIC Primary Peritoneal Cancer AJCC v7
  • Recurrent Primary Peritoneal Carcinoma
  • Recurrent Ovarian Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Stage IIIC Uterine Corpus Cancer AJCC v7

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From time-of-study entry to time-of-detection of new lesions on computed tomography imaging that is triggered by CA125 progression as defined by Gynecologic Cancer Intergroup Criteria (GCIG) or clinical symptoms or deterioration, assessed up to 3 years

Year 3
Progression-free survival (PFS)
Month 15
Quality of life (QoL) assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QoL questionnaire
Month 3
Incidence of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) guidelines

Trial Safety

Safety Progress

1 of 3

Other trials for Stage IIIC Uterine Corpus Cancer AJCC v7

Trial Design

1 Treatment Group

Treatment (surgery, HIPEC cisplatin)
1 of 1
Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Cisplatin · No Placebo Group · Phase 1

Treatment (surgery, HIPEC cisplatin)Experimental Group · 8 Interventions: Cisplatin, Carboplatin, Gemcitabine Hydrochloride, Quality-of-Life Assessment, Paclitaxel, Therapeutic Conventional Surgery, Laboratory Biomarker Analysis, Pegylated Liposomal Doxorubicin Hydrochloride · Intervention Types: Drug, Drug, Drug, Other, Drug, Procedure, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chloride ion
Not yet FDA approved
Carboplatin
FDA approved
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410
Tetracycline
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from time-of-study entry to time-of-detection of new lesions on computed tomography imaging that is triggered by ca125 progression as defined by gynecologic cancer intergroup criteria (gcig) or clinical symptoms or deterioration, assessed up to 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,848 Total Patients Enrolled
11 Trials studying Stage IIIC Uterine Corpus Cancer AJCC v7
3,440 Patients Enrolled for Stage IIIC Uterine Corpus Cancer AJCC v7
City of Hope Medical CenterLead Sponsor
505 Previous Clinical Trials
2,248,987 Total Patients Enrolled
Thanh DellingerPrincipal InvestigatorCity of Hope Medical Center

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Neoadjuvant chemotherapy must be stopped at least 3 weeks before surgery.
in the protocol No clinically significant adverse effects from previous treatments (except hair loss and peripheral neuropathy) that are currently at a grade of 1 or lower according to the NCI CTCAE scale, and that have returned to baseline values as defined in the protocol.
A person has a Gynecologic Oncology Group (GOG) or Eastern Cooperative Oncology Group (ECOG) performance status of less than 1 or a Karnofsky scale of 70% or greater.
are those who have tumors that respond to platinum-containing chemotherapy drugs
There has been a decline in the serum cancer antigen (CA) 125 level.
You have a 30% or more decrease in the sum of the longest diameter of target lesions on radiographic imaging.
The volume of ascites was improved.
Patients who have stage III or IV ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, or who have recurrent cancer, are considered for cytoreductive surgery
A patient may be a candidate for radical, maximal effort cytoreductive surgery if the doctor believes it is the best option for them.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: October 5th, 2022

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.