Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer - Full Text View

Sponsor:	Nordic Society for Gynaecologic Oncology
Collaborators:	European Organization for Research and Treatment of Cancer - EORTC NCIC Clinical Trials Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004934

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether receiving paclitaxel and carboplatin with epirubicin is more effective than paclitaxel and carboplatin alone for ovarian epithelial, fallopian tube, or peritoneal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with or without epirubicin in treating patients who have stage IIB, stage III, or stage IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer.

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer	Drug: carboplatin Drug: epirubicin hydrochloride Drug: paclitaxel Procedure: conventional surgery	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	A Randomized Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) Versus Paclitaxel/Carboplatin (TC) in the Treatment of Women With Advanced Ovarian Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

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

Study Start Date:

August 1999

Detailed Description:

OBJECTIVES:

Compare progression free survival and overall survival in patients with stage IIB, III, or IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer treated with paclitaxel and carboplatin with or without epirubicin.
Compare the toxicity of these 2 regimens in these patients.
Compare the quality of life of patients treated with these 2 regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and type of surgery (delayed surgery: 3 courses of chemotherapy before surgery vs primary surgery: optimally debulked stage IIB or III [residual tumor less than 1 cm] vs primary surgery: suboptimally debulked stage IV [residual tumor 1 cm or greater]).

Surgery

Patients are assigned to one of two surgery groups:
Group A: Patients undergo primary surgery comprised of hysterectomy, bilateral salpingo-oophorectomy (BSO), omentectomy, and resection of all tumor masses, if possible, before beginning chemotherapy. Patients with residual disease greater than 1 cm after completion of primary surgery receive 3 courses of chemotherapy, followed within 6 weeks by interval debulking surgery, followed within 3 weeks by the fourth course of chemotherapy.
Group B: Patients undergo delayed surgery comprised of hysterectomy, BSO, omentectomy, and resection of all tumor masses, if possible, after completion of 3 courses of chemotherapy.

Chemotherapy

Patients are randomized to 1 of 2 chemotherapy arms:
Arm I: Patients receive epirubicin IV over 15-20 minutes, paclitaxel IV over 3 hours, and carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients with residual tumor after completion of 6 courses may receive 3 additional courses.
Arm II: Patients receive paclitaxel and carboplatin as above but no epirubicin. Quality of life is assessed before beginning study, after completion of courses 3, 6, and 9 (if applicable), and then at 6 and 12 months after completion of study treatment.

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

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically proven stage IIB, III, or IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer
No symptomatic brain metastasis

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

WHO/ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm^3
Neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 2 times upper limit of normal

Renal:

Glomerular filtration rate at least 50 mL/min

Cardiovascular:

No ventricular arrhythmia (LOWN class II or worse)
No myocardial infarction within the past year
No severe or uncontrolled hypertension
No history of congestive heart disease (no New York Heart Association class III or IV heart disease) even if medically controlled
LVEF at least 50%

Other:

No other primary malignancies except carcinoma in situ of the cervix or basal cell skin cancer
No worse than grade I preexisting motor or sensory neurologic pathology or symptoms
No active infection or other serious underlying medical condition that would prevent compliance
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy
No other concurrent antineoplastic agents

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004934

Locations

United States, Minnesota
St. Mary's/Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
Belgium
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Canada, Quebec
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Denmark
Aalborg Hospital
Aalborg, Denmark, 9100
Odense University Hospital
Odense, Denmark, DK-5000
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Italy
Spedali Civili
Brescia, Italy, 25123
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), Italy, 20133
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Netherlands
Medisch Spectrum Twente
Enschede, Netherlands, 7500 KA
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Portugal
Hospitais da Universidade de Coimbra (HUC)
Coimbra, Portugal, 3049
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
Lisbon, Portugal, 1099-023 Codex
Spain
Institut d'Oncologia Corachan
Barcelona, Spain, 08.017

Sponsors and Collaborators

Nordic Society for Gynaecologic Oncology

European Organization for Research and Treatment of Cancer - EORTC

NCIC Clinical Trials Group

Investigators

Study Chair:	Gunnar B. Kristensen, MD, PhD	Norwegian Radium Hospital
Study Chair:	Ignace B. Vergote, MD, PhD	U.Z. Gasthuisberg
Study Chair:	Gavin C.E. Stuart, MD	Tom Baker Cancer Centre - Calgary

More Information

Additional Information:

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

Publications:

Kristensen GB, Vergote I, Stuart G, Del Campo JM, Kaern J, Lopez AB, Eisenhauer E, Aavall-Lundquist E, Ridderheim M, Havsteen H, Mirza MR, Scheistroen M, Vrdoljak E. First-line treatment of ovarian cancer FIGO stages IIb-IV with paclitaxel/epirubicin/carboplatin versus paclitaxel/carboplatin. Int J Gynecol Cancer. 2003 Nov-Dec;13 Suppl 2:172-7.

Kristensen G, Vergote I, Stuart G, et al.: First line treatment of ovarian cancer FIGO stages IIb-IV with paclitaxel/epirubicin/carboplatin (TEC) vs. paclitaxel/carboplatin (TC). Interim results of an NSGO-EORTC-NCIC CTG Gynecological Cancer Intergroup phase III trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-805, 2002.

Kristensen GB, Vergote I, Stuart G, et al.: First-line treatment of ovarian/tubal/peritoneal cancer FIGO stage IIB-IV with paclitaxel/carboplatin with or without epirubicin (TEC vs TC). A gynecologic cancer intergroup study of the NSGO, EORTC GCG, and NCIC CTG. Results on progression-free survival. [Abstract] Int J Gynecol Cancer 15 (Suppl 3): 221, 2005.

Kristensen GB, Vergote I, Eisenhauer E, et al.: First line treatment of ovarian/tubal/peritoneal cancer FIGO stage IIb-IV with paclitaxel/carboplatin with or without epirubicin (TEC vs TC). A Gynecologic Cancer Intergroup study of the NSGO, EORTC GCG, and NCIC CTG. Results on progression free survival. [Abstract] J Clin Oncol 22 (Suppl 14): A-5003, 449s, 2004.

ClinicalTrials.gov Identifier:	NCT00004934 History of Changes
Other Study ID Numbers:	CDR0000067620, NSGO-OC9804, CAN-NCIC-OV14, EORTC-55981
Study First Received:	March 7, 2000
Last Updated:	April 23, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms

Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Epirubicin
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012