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

This study has been completed.
Sponsor:
Collaborators:
Nordic Society for Gynaecologic Oncology
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by (Responsible Party):
AGO Study Group
ClinicalTrials.gov Identifier:
NCT00052468
First received: January 24, 2003
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Drug: TCG
Drug: TC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Whole Study Period ] [ Designated as safety issue: No ]
    Survival time is calculated from the date of enrollment into the study until the date of death from any cause


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Whole Study Period ] [ Designated as safety issue: No ]
    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:
  • Quality of Life [ Time Frame: Whole Study Period ] [ Designated as safety issue: No ]

Enrollment: 1742
Study Start Date: August 2002
Study Completion Date: January 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • 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

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal

Renal

  • Glomerular filtration rate at least 50 mL/min

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy except:

    • Hormone replacement therapy
    • Antiemetic steroids

Radiotherapy

  • No prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • No other concurrent antineoplastic agents
  • No other concurrent investigational drugs
  • No other concurrent clinical trial enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052468

Locations
Denmark
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, Denmark, DK2730
France
Hotel Dieu de Paris
Paris, France, 75181
Germany
Zentralkrankenhaus
Bremen, Germany, D-28205
Evangelisches Krankenhaus
Dusseldorf, Germany, DOH-40217
Universitaetsklinikum Essen
Essen, Germany, D-45122
Staedtische Kliniken Frankfurt am Main - Hoechst
Frankfurt, Germany, D-65929
Frauenklinik der MHH
Hannover, Germany, 30659
Vincentius Krankenhaus
Karlsruhe, Germany, D-76137
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24105
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany, 39108
Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster
Muenster, Germany, D-48129
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
Munich, Germany, D-81377
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Universitaetsklinikum Tuebingen
Tuebingen, Germany, D-72076
Universitaet Ulm
Ulm, Germany, D-89075
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany, D-65199
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Sponsors and Collaborators
AGO Study Group
Nordic Society for Gynaecologic Oncology
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AGO Study Group
ClinicalTrials.gov Identifier: NCT00052468     History of Changes
Other Study ID Numbers: CDR0000258429, AGO-OVAR9, NORDIC-AGO-OVAR-9, GERCOR-AGO-OVAR-9, EU-20241
Study First Received: January 24, 2003
Last Updated: June 24, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014