Clinical trial · Interventional
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
NCT00011986CI-TRIAL-00038149completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage III Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pegylated Liposomal Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
| Topotecan Hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients 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.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients 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.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Gemcitabine Hydrochloride
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * 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: * Stage no greater than IB * Less than 3 mm invasion without vascular or lymphatic invasion * No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions * Performance status - GOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * No acute hepatitis * Creatinine no greater than 1.5 times ULN * No unstable angina * No myocardial infarction within the past 6 months * No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) unless stable for the past 6 months * Not pregnant or nursing * Fertile patients must use effective contraception * No greater than grade 1 sensory or motor neuropathy * No active infection that requires antibiotics * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No severe or ongoing gastrointestinal bleeding that requires blood product support * See Disease Characteristics * Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true: * More than 3 years since prior therapy * No evidence of recurrent disease * No prior radiotherapy to any portion of the abdominal cavity or pelvis * Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true: * More than 3 years since prior therapy * No evidence of recurrent disease * See Disease Characteristics * No more than 12 weeks since prior surgical resection
References
Publications (5)
- DERIVEDPraiss 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 37229879
- DERIVEDSia 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 37148580
- DERIVEDRose 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 30633128
- DERIVEDHan 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 24779680
- DERIVEDNickles 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.