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

Ovarian Cancer Clinical Trial

Official title:

A Randomized Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) Versus Paclitaxel/Carboplatin (TC) in the Treatment of Women With Advanced Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004934
• Other study ID #: CDR0000067620
• Secondary ID: NSGO-OC9804CAN-N
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2000
• Last updated: February 1, 2013
• Start date: August 1999
• Est. completion date: May 2003

Study information

• Verified date: May 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• carboplatin

• epirubicin hydrochloride

• paclitaxel

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Belgium	U.Z. Gasthuisberg	Leuven
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Denmark	Aalborg Hospital	Aalborg
Denmark	Odense University Hospital	Odense
Israel	Shaare Zedek Medical Center	Jerusalem
Italy	Spedali Civili	Brescia
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Milano (Milan)
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Netherlands	Medisch Spectrum Twente	Enschede
Norway	Norwegian Radium Hospital	Oslo
Portugal	Hospitais da Universidade de Coimbra (HUC)	Coimbra
Portugal	Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa	Lisbon
Spain	Institut d'Oncologia Corachan	Barcelona
United States	St. Mary's/Duluth Clinic Cancer Center	Duluth	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Nordic Society for Gynaecologic Oncology	Canadian Cancer Trials Group, European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

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

References & Publications (5)

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 ph

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

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/carb — View Citation

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 NCI

Lindemann K, Christensen RD, Vergote I, Stuart G, Izquierdo MA, Kærn 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/car — View Citation