Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma
8 other identifiers
interventional
4,312
1 country
1
Brief Summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2001
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
March 3, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2013
CompletedResults Posted
Study results publicly available
April 19, 2016
CompletedApril 16, 2019
March 1, 2016
9.2 years
March 3, 2001
February 18, 2014
April 3, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival
Proportion of participants whose overall survival exceeded 5 years.
Up to 9 years
Progression-free Survival
Median duration in months of progression free survival.
From the date of enrollment to first progression or death or last contact, if alive and progression free.
Secondary Outcomes (1)
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0
Up to 9 years
Study Arms (5)
Arm I
ACTIVE COMPARATORPatients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Arm II
EXPERIMENTALPatients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Arm III
EXPERIMENTALPatients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I.
Arm IV
EXPERIMENTALPatients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy.
Arm V
EXPERIMENTALPatients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed stage III or IV ovarian epithelial or serous primaryperitoneal carcinoma
- The following are ineligible:
- Germ cell tumors
- Sex cord-stromal tumors
- Carcinosarcomas
- Mixed Mullerian tumors or carcinosarcomas
- Metastatic carcinomas from other sites to theovary
- Low malignant potential tumors, including micropapillary serouscarcinomas
- Mucinous primary peritoneal carcinoma
- Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy
- Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
- Prior breast cancer allowed provided the following are true:
- Disease-free for more than 5 years
- No prior cytotoxic chemotherapy for breast cancer
- Prior or concurrent primary endometrial cancer allowed if the following conditions are met:
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- SWOG Cancer Research Networkcollaborator
- Medical Research Councilcollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
Related Publications (5)
Praiss AM, Miller A, Smith J, Lichtman SM, Bookman M, Aghajanian C, Sabbatini P, Backes F, Cohn DE, Argenta P, Friedlander M, Goodheart MJ, Mutch DG, Gershenson DM, Tewari KS, Wenham RM, Wahner Hendrickson AE, Lee RB, Gray H, Secord AA, Van Le L, O'Cearbhaill RE. Carboplatin dosing in the treatment of ovarian cancer: An NRG oncology group study. Gynecol Oncol. 2023 Jul;174:213-223. doi: 10.1016/j.ygyno.2023.05.013. Epub 2023 May 23.
PMID: 37229879DERIVEDSia TY, Tew WP, Purdy C, Chi DS, Menzin AW, Lovecchio JL, Bookman MA, Cohn DE, Teoh DG, Friedlander M, Bender D, Mutch DG, Gershenson DM, Tewari KS, Wenham RM, Wahner Hendrickson AE, Lee RB, Gray HJ, Secord AA, Van Le L, Lichtman SM. The effect of older age on treatment outcomes in women with advanced ovarian cancer receiving chemotherapy: An NRG-Oncology/Gynecologic Oncology Group (GOG-0182-ICON5) ancillary study. Gynecol Oncol. 2023 Jun;173:130-137. doi: 10.1016/j.ygyno.2023.03.018. Epub 2023 May 4.
PMID: 37148580DERIVEDRose PG, Java JJ, Salani R, Geller MA, Secord AA, Tewari KS, Bender DP, Mutch DG, Friedlander ML, Van Le L, Method MW, Hamilton CA, Lee RB, Wenham RM, Guntupalli SR, Markman M, Muggia FM, Armstrong DK, Bookman MA, Burger RA, Copeland LJ. Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma. Obstet Gynecol. 2019 Feb;133(2):245-254. doi: 10.1097/AOG.0000000000003086.
PMID: 30633128DERIVEDHan MK, Tayob N, Murray S, Dransfield MT, Washko G, Scanlon PD, Criner GJ, Casaburi R, Connett J, Lazarus SC, Albert R, Woodruff P, Martinez FJ. Predictors of chronic obstructive pulmonary disease exacerbation reduction in response to daily azithromycin therapy. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1503-8. doi: 10.1164/rccm.201402-0207OC.
PMID: 24779680DERIVEDNickles Fader A, Java J, Ueda S, Bristow RE, Armstrong DK, Bookman MA, Gershenson DM; Gynecologic Oncology Group (GOG)*. Survival in women with grade 1 serous ovarian carcinoma. Obstet Gynecol. 2013 Aug;122(2 Pt 1):225-232. doi: 10.1097/AOG.0b013e31829ce7ec.
PMID: 23969788DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Gedeon, BS, CCRP
- Organization
- Gynecologic Oncology Group Statistical and Data Center
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bookman
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2001
First Posted
January 27, 2003
Study Start
January 1, 2001
Primary Completion
March 1, 2010
Study Completion
January 28, 2013
Last Updated
April 16, 2019
Results First Posted
April 19, 2016
Record last verified: 2016-03