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

NCT ID: NCT00004934

Last Updated: 2013-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31
• Study Completion Date: 2003-05-31

Brief Summary

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.

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role: collaborator

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

OTHER

Sponsor Role: lead

Principal Investigators

Gunnar B. Kristensen, MD, PhD

Role: STUDY_CHAIR

Norwegian Radium Hospital

Ignace B. Vergote, MD, PhD

Role: STUDY_CHAIR

University Hospital, Gasthuisberg

Gavin C.E. Stuart, MD

Role: STUDY_CHAIR

Tom Baker Cancer Centre - Calgary

Locations

St. Mary's/Duluth Clinic Cancer Center

Duluth, Minnesota, United States

U.Z. Gasthuisberg

Leuven, , Belgium

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, Canada

CHUS-Hopital Fleurimont

Fleurimont, Quebec, Canada

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, Canada

Aalborg Hospital

Aalborg, , Denmark

Odense University Hospital

Odense, , Denmark

Shaare Zedek Medical Center

Jerusalem, , Israel

Spedali Civili

Brescia, , Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milano (Milan), , Italy

Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Medisch Spectrum Twente

Enschede, , Netherlands

Norwegian Radium Hospital

Oslo, , Norway

Hospitais da Universidade de Coimbra (HUC)

Coimbra, , Portugal

Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

Lisbon, , Portugal

Institut d'Oncologia Corachan

Barcelona, , Spain

Countries

United States; Belgium; Canada; Denmark; Israel; Italy; Netherlands; Norway; Portugal; Spain

References

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. doi: 10.1111/j.1525-1438.2003.13363.x.

Reference Type: RESULT

PMID: 14656276 (View on PubMed)

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.

Reference Type: RESULT

Lindemann K, Christensen RD, Vergote I, Stuart G, Izquierdo MA, Kaern J, Havsteen H, Eisenhauer E, Ridderheim M, Lopez AB, Hirte H, Aavall-Lundquvist E, Vrdoljak E, Green J, Kristensen GB. First-line treatment of advanced ovarian cancer with paclitaxel/carboplatin with or without epirubicin (TEC versus TC)--a gynecologic cancer intergroup study of the NSGO, EORTC GCG and NCIC CTG. Ann Oncol. 2012 Oct;23(10):2613-2619. doi: 10.1093/annonc/mds060. Epub 2012 Apr 26.

Reference Type: RESULT

PMID: 22539562 (View on PubMed)

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.

Reference Type: RESULT

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.

Reference Type: RESULT

Other Identifiers

NSGO-OC9804

Identifier Type: -

Identifier Source: secondary_id

CAN-NCIC-OV14

Identifier Type: -

Identifier Source: secondary_id

EORTC-55981

Identifier Type: -

Identifier Source: secondary_id

CDR0000067620

Identifier Type: -

Identifier Source: org_study_id