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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TCG
TC
Sponsored by
AGO Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev Hospital - University Hospital of Copenhagen
  • Hotel Dieu de Paris
  • Zentralkrankenhaus
  • Evangelisches Krankenhaus
  • Universitaetsklinikum Essen
  • Staedtische Kliniken Frankfurt am Main - Hoechst
  • Frauenklinik der MHH
  • Vincentius Krankenhaus
  • University Hospital Schleswig-Holstein - Kiel Campus
  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
  • Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster
  • Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen
  • Universitaetsklinikum Tuebingen
  • Universitaet Ulm
  • Dr. Horst-Schmidt-Kliniken
  • Norwegian Radium Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TCG

TC

Arm Description

Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses

Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses

Outcomes

Primary Outcome Measures

Overall Survival
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
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

Full Information

First Posted
January 24, 2003
Last Updated
June 24, 2014
Sponsor
AGO Study Group
Collaborators
Nordic Society of Gynaecological Oncology - Clinical Trials Unit, GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00052468
Brief Title
Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
Acronym
AGO-OVAR9
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGO Study Group
Collaborators
Nordic Society of Gynaecological Oncology - Clinical Trials Unit, GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1742 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TCG
Arm Type
Experimental
Arm Description
Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses
Arm Title
TC
Arm Type
Active Comparator
Arm Description
Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses
Intervention Type
Drug
Intervention Name(s)
TCG
Other Intervention Name(s)
Paclitaxel/Carboplatin/Gemcitabine
Intervention Type
Drug
Intervention Name(s)
TC
Other Intervention Name(s)
Paclitaxel/Carboplatin
Primary Outcome Measure Information:
Title
Overall Survival
Description
Survival time is calculated from the date of enrollment into the study until the date of death from any cause
Time Frame
Whole Study Period
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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
Time Frame
Whole Study Period
Other Pre-specified Outcome Measures:
Title
Quality of Life
Time Frame
Whole Study Period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas du Bois, MD, PhD
Organizational Affiliation
Dr. Horst-Schmidt-Kliniken
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
J. Herrstedt
Organizational Affiliation
Copenhagen County Herlev University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
E. Pujade-Lauraine, MD, PhD
Organizational Affiliation
Hotel Dieu de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Herlev Hospital - University Hospital of Copenhagen
City
Copenhagen
ZIP/Postal Code
DK2730
Country
Denmark
Facility Name
Hotel Dieu de Paris
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Zentralkrankenhaus
City
Bremen
ZIP/Postal Code
D-28205
Country
Germany
Facility Name
Evangelisches Krankenhaus
City
Dusseldorf
ZIP/Postal Code
DOH-40217
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Staedtische Kliniken Frankfurt am Main - Hoechst
City
Frankfurt
ZIP/Postal Code
D-65929
Country
Germany
Facility Name
Frauenklinik der MHH
City
Hannover
ZIP/Postal Code
30659
Country
Germany
Facility Name
Vincentius Krankenhaus
City
Karlsruhe
ZIP/Postal Code
D-76137
Country
Germany
Facility Name
University Hospital Schleswig-Holstein - Kiel Campus
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
City
Magdeburg
ZIP/Postal Code
39108
Country
Germany
Facility Name
Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
D-48129
Country
Germany
Facility Name
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Universitaet Ulm
City
Ulm
ZIP/Postal Code
D-89075
Country
Germany
Facility Name
Dr. Horst-Schmidt-Kliniken
City
Wiesbaden
ZIP/Postal Code
D-65199
Country
Germany
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20733132
Citation
du Bois A, Herrstedt J, Hardy-Bessard AC, Muller HH, Harter P, Kristensen G, Joly F, Huober J, Avall-Lundqvist E, Weber B, Kurzeder C, Jelic S, Pujade-Lauraine E, Burges A, Pfisterer J, Gropp M, Staehle A, Wimberger P, Jackisch C, Sehouli J. Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer. J Clin Oncol. 2010 Sep 20;28(27):4162-9. doi: 10.1200/JCO.2009.27.4696. Epub 2010 Aug 23.
Results Reference
result
PubMed Identifier
21410972
Citation
Machelon V, Gaudin F, Camilleri-Broet S, Nasreddine S, Bouchet-Delbos L, Pujade-Lauraine E, Alexandre J, Gladieff L, Arenzana-Seisdedos F, Emilie D, Prevot S, Broet P, Balabanian K. CXCL12 expression by healthy and malignant ovarian epithelial cells. BMC Cancer. 2011 Mar 16;11:97. doi: 10.1186/1471-2407-11-97.
Results Reference
derived

Learn more about this trial

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

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