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NCT00011986 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2019-04-16

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
sex
FEMALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Carboplatin
    label
    Arm I
    type
    ACTIVE_COMPARATOR
  2. 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.
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Carboplatin
    3. Drug: Gemcitabine Hydrochloride
    label
    Arm II
    type
    EXPERIMENTAL
  3. description
    Patients 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.
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Carboplatin
    3. Drug: Pegylated Liposomal Doxorubicin Hydrochloride
    label
    Arm III
    type
    EXPERIMENTAL
  4. description
    Patients 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.
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Carboplatin
    3. Drug: Topotecan Hydrochloride
    label
    Arm IV
    type
    EXPERIMENTAL
  5. description
    Patients 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.
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Carboplatin
    3. Drug: Gemcitabine Hydrochloride
    4. Procedure: Therapeutic Conventional Surgery
    label
    Arm V
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    2. Arm II
    3. Arm III
    4. Arm IV
    5. Arm V
    description
    Given IV
    name
    Paclitaxel
    other Names
    1. Anzatax
    2. TAX
    type
    DRUG
  2. arm Group Labels
    1. Arm I
    2. Arm II
    3. Arm III
    4. Arm IV
    5. Arm V
    description
    Given IV
    name
    Carboplatin
    type
    DRUG
  3. arm Group Labels
    1. Arm II
    2. Arm V
    description
    Given IV
    name
    Gemcitabine Hydrochloride
    other Names
    1. dFdC
    2. dFdCyd
    type
    DRUG
  4. arm Group Labels
    1. Arm III
    name
    Pegylated Liposomal Doxorubicin Hydrochloride
    other Names
    1. doxorubicin HCl liposome
    2. TLC D-99
    type
    DRUG
  5. arm Group Labels
    1. Arm IV
    description
    Given IV
    name
    Topotecan Hydrochloride
    other Names
    1. Hycamtin
    2. SKF S-104864-A
    3. TOPO
    type
    DRUG
  6. arm Group Labels
    1. Arm V
    description
    Undergo surgery
    name
    Therapeutic Conventional Surgery
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
4312
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Proportion of participants whose overall survival exceeded 5 years.
    measure
    Overall Survival
    time Frame
    Up to 9 years
  2. description
    Median duration in months of progression free survival.
    measure
    Progression-free Survival
    time Frame
    From the date of enrollment to first progression or death or last contact, if alive and progression free.
secondary Outcomes
  1. measure
    Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0
    time Frame
    Up to 9 years
Full study description
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.
detailed Description
OBJECTIVES: Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine, doxorubicin HCl liposome, or topotecan, in terms of overall and progression-free survival, in patients with stage III or IV ovarian epithelial or serous primary peritoneal carcinoma. Determine the response rate in patients with measurable disease treated with these regimens. Compare the toxic effects of these regimens in these patients. Compare the complications in patients treated with these regimens. Determine the dose-intensity and cumulative dose delivery for these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery: Stratum A: Optimal (microscopic or macroscopic) residual disease without plans for surgery Stratum B: Suboptimal residual disease without plans for surgery Stratum C: Suboptimal residual disease with plans for surgeryPatients are randomized to 1 of 5 treatment arms. Arm I: 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. Arm II: Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues as in arm I. Arm III: Patients 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: Patients 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: Patients 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. Patients are followed every 3 months for 2 years and then every 6 months. PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be accrued for this study within 3.5-5 years.
Source references
references
  1. citation
    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
    37229879
    type
    DERIVED
  2. citation
    Sia 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
    type
    DERIVED
  3. citation
    Rose 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
    type
    DERIVED
  4. citation
    Han 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
    type
    DERIVED
  5. citation
    Nickles 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
    23969788
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        C1</a>]</p> <p id="_740" tabindex="-1">However, in an analysis of 2,655 of the 4,312 patients enrolled in the largest GOG study (<a href="/clinicaltrials/NCT00011986">GOG-0182</a> [NCT00011986]), only cytoreduction to nonvisible disease that is R0 (i.e., complete surgical resection) had an independent effect on survival. Fo
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        40" tabindex="-1">However, in an analysis of 2,655 of the 4,312 patients enrolled in the largest GOG study (<a href="/clinicaltrials/NCT00011986">GOG-0182</a> [NCT00011986]), only cytoreduction to nonvisible disease that is R0 (i.e., complete surgical resection) had an independent effect on survival. For more information, see the
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      3. context exact
        wer-alpha"><li>From 2001 to 2004, 4,312 women with stage III or stage IV ovarian epithelial cancer, FTC, or PPC participating in the <a href="/clinicaltrials/NCT00011986">GOG-0182</a> trial were randomly assigned to four different experimental arms or to a reference treatment consisting of carboplatin (area under the curve [AUC
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      Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice