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

Ovarian Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00052468
• Other study ID #: CDR0000258429
• Secondary ID: AGO-OVAR9NORDIC-
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2003
• Last updated: June 24, 2014
• Start date: August 2002
• Est. completion date: January 2011

Study information

• Verified date: June 2014
• Source: AGO Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1742
• Est. completion date: January 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• TCG

• TC

Locations

Country	Name	City	State
Denmark	Herlev Hospital - University Hospital of Copenhagen	Copenhagen
France	Hotel Dieu de Paris	Paris
Germany	Zentralkrankenhaus	Bremen
Germany	Evangelisches Krankenhaus	Dusseldorf
Germany	Universitaetsklinikum Essen	Essen
Germany	Staedtische Kliniken Frankfurt am Main - Hoechst	Frankfurt
Germany	Frauenklinik der MHH	Hannover
Germany	Vincentius Krankenhaus	Karlsruhe
Germany	University Hospital Schleswig-Holstein - Kiel Campus	Kiel
Germany	Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg	Magdeburg
Germany	Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster	Muenster
Germany	Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen	Munich
Germany	Klinikum Rechts Der Isar - Technische Universitaet Muenchen	Munich
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	Universitaet Ulm	Ulm
Germany	Dr. Horst-Schmidt-Kliniken	Wiesbaden
Norway	Norwegian Radium Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
AGO Study Group	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR), Nordic Society for Gynaecologic Oncology

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Norway, 

References & Publications (1)

du Bois A, Herrstedt J, Hardy-Bessard AC, Müller 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 tri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life		Whole Study Period	No
Primary	Overall Survival	Survival time is calculated from the date of enrollment into the study until the date of death from any cause	Whole Study Period	No
Secondary	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	Whole Study Period	No