Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer - Full Text View

Sponsors and Collaborators:	AGO Ovarian Cancer Study Group Nordic Society for Gynaecologic Oncology Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052468

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: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery	Phase III

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Gemcitabine hydrochloride Gemcitabine Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	A Multi-National Randomized Phase III GCIG Intergroup Study Comparing 1st Line Chemotherapy With Gemcitabine, Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2002

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

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
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany, D-65199
Evangelisches Krankenhaus
Dusseldorf, Germany, DOH-40217
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster
Muenster, Germany, D-48129
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
Munich, Germany, D-81377
Frauenklinik der MHH
Hannover, Germany, 30659
Staedtische Kliniken Frankfurt am Main - Hoechst
Frankfurt, Germany, D-65929
Universitaet Ulm
Ulm, Germany, D-89075
Universitaetsklinikum Essen
Essen, Germany, D-45122
Universitaetsklinikum Tuebingen
Tuebingen, Germany, D-72076
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany, 39108
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24105
Vincentius Krankenhaus
Karlsruhe, Germany, D-76137
Zentralkrankenhaus
Bremen, Germany, D-28205
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310

Sponsors and Collaborators

AGO Ovarian Cancer 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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000258429, AGO-OVAR-9, NORDIC-AGO-OVAR-9, GERCOR-AGO-OVAR-9, EU-20241
Study First Received:	January 24, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00052468
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer

Study placed in the following topic categories:

Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Carboplatin
Ovarian Diseases
Ovarian epithelial cancer

Fallopian Tube Neoplasms
Fallopian Tube Diseases
Genital Diseases, Female
Paclitaxel
Endocrinopathy
Fallopian tube cancer
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009