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Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer (AGO-OVAR9)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00052468
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 25, 2014
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
GERCOR - Multidisciplinary Oncology Cooperative Group
Information provided by (Responsible Party):
AGO Study Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Drug: TCG Drug: TC Phase 3

Detailed Description:


  • Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian tube cancer treated with adjuvant carboplatin and paclitaxel with or without gemcitabine.
  • Compare response rates, progression-free survival, and duration of response in patients treated with these regimens.
  • Compare toxic effects of these regimens in these patients.
  • Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
  • Arm II: Patients receive carboplatin and paclitaxel as in arm I. Treatment in both arms repeats every 21 days for 6 to 10 courses in the absence of disease progression or unacceptable toxicity.

Some patients undergo interval debulking surgery.

Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study.

Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1742 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV
Study Start Date : August 2002
Actual Primary Completion Date : July 2009
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: TCG
Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses
Drug: TCG
Other Name: Paclitaxel/Carboplatin/Gemcitabine

Active Comparator: TC
Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses
Drug: TC
Other Name: Paclitaxel/Carboplatin

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Whole Study Period ]
    Survival time is calculated from the date of enrollment into the study until the date of death from any cause

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Whole Study Period ]
    The progression-free survival is calculated for all patients from the date of enrollment until the date of first progressive disease or death, whichever occurs first

Other Outcome Measures:
  1. Quality of Life [ Time Frame: Whole Study Period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed diagnosis of one of the following:

    • Ovarian epithelial cancer

      • FIGO stage IA/B G3, IC-IV
    • Fallopian tube cancer
    • Extra-ovarian papillary serous tumor
  • The following are ineligible:

    • Low malignant-potential ovarian tumors (borderline tumors)
    • Non-epithelial ovarian tumors
    • Mixed Mullerian tumors
  • Must have had definitive surgery within the past 6 weeks
  • No symptomatic brain metastases



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months


  • WBC at least 3,000/mm^3 OR
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 10 mg/dL


  • Bilirubin no greater than 2 times upper limit of normal


  • Glomerular filtration rate at least 50 mL/min


  • No congestive heart failure
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart disease
  • No prior atrial or ventricular arrhythmias


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior seizures or central nervous system disorder
  • No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K)
  • No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel
  • No preexisting motor or sensory neuropathy greater than grade 1
  • No other malignancy within the past 5 years except:

    • Malignancies cured by surgery alone
    • Carcinoma in situ of the cervix
    • Adequately treated basal cell skin cancer
  • No complete bowel obstruction
  • No other concurrent severe medical condition that would preclude study participation
  • No dementia or significantly altered mental status that would preclude study participation
  • No concurrent severe active infection
  • Geographically accessible for treatment and follow-up


Biologic therapy

  • No concurrent immunotherapy


  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy except:

    • Hormone replacement therapy
    • Antiemetic steroids


  • No prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery


  • No other concurrent antineoplastic agents
  • No other concurrent investigational drugs
  • No other concurrent clinical trial enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00052468

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Sponsors and Collaborators
AGO Study Group
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
GERCOR - Multidisciplinary Oncology Cooperative Group
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Study Chair: Andreas du Bois, MD, PhD Dr. Horst-Schmidt-Kliniken
Study Chair: J. Herrstedt Copenhagen County Herlev University Hospital
Study Chair: E. Pujade-Lauraine, MD, PhD Hotel Dieu de Paris
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AGO Study Group Identifier: NCT00052468    
Other Study ID Numbers: CDR0000258429
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Keywords provided by AGO Study Group:
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents