Phase 3
Completed N=4,312
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Source: ClinicalTrials.gov NCT00011986 ↗Enrolled (actual)
4,312
Serious AEs
12.6%
Results posted
Apr 2016
Primary outcomePrimary: Overall Survival — 0.35; 0.34; 0.39; 0.34 Proportion of participants
◆ Published Evidence
Highly cited
194citations · ~16 / year
Predictors of chronic obstructive pulmonary disease exacerbation reduction in response to daily azithromycin therapy.
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.
Linked Publications (5)
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Predictors of chronic obstructive pulmonary disease exacerbation reduction in response to daily azithromycin therapy.
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Survival in women with grade 1 serous ovarian carcinoma.
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Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma.
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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.
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Carboplatin dosing in the treatment of ovarian cancer: An NRG oncology group study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
0.35; 0.34; 0.39; 0.34; 0.30 | — |
| PRIMARY Progression-free Survival |
16.0; 16.3; 16.4; 15.4; 15.4 | — |
| SECONDARY Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 |
438; 686; 595; 476; 513; 749 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00011986) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.