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

Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit (Other)

Overall Status

Completed

CT.gov ID

NCT00004934

Collaborator

European Organisation for Research and Treatment of Cancer - EORTC (Other), NCIC Clinical Trials Group (Other)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer	Drug: carboplatin Drug: epirubicin hydrochloride Drug: paclitaxel Procedure: conventional surgery	Phase 3

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.

Study Design

Study Type:

Interventional

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

Study Start Date :

Aug 1, 1999

Actual Study Completion Date :

May 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

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