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
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
Intervention: carboplatin (Drug); epirubicin hydrochloride (Drug); paclitaxel (Drug); conventional surgery (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: Nordic Society for Gynaecologic Oncology Official(s) and/or principal investigator(s):
Gunnar B. Kristensen, MD, PhD, Study Chair, Affiliation: Norwegian Radium Hospital
Ignace B. Vergote, MD, PhD, Study Chair, Affiliation: U.Z. Gasthuisberg
Gavin C.E. Stuart, MD, Study Chair, Affiliation: Tom Baker Cancer Centre - Calgary
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.
Clinical Details
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 design: Treatment, Randomized, Active Control
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
U.Z. Gasthuisberg, Leuven B-3000, Belgium
Aalborg Hospital, Aalborg 9100, Denmark
Odense University Hospital, Odense DK-5000, Denmark
Shaare Zedek Medical Center, Jerusalem 91031, Israel
Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano (Milan) 20133, Italy
Ospedale di Circolo e Fondazione Macchi, Varese 21100, Italy
Spedali Civili, Brescia 25123, Italy
Medisch Spectrum Twente, Enschede 7500 KA, Netherlands
Norwegian Radium Hospital, Oslo N-0310, Norway
Hospitais da Universidade de Coimbra (HUC), Coimbra 3049, Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa, Lisbon 1099-023 Codex, Portugal
Institut d'Oncologia Corachan, Barcelona 08.017, Spain
Tom Baker Cancer Center - Calgary, Calgary, Alberta T2N 4N2, Canada
CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada
St. Mary's/Duluth Clinic Cancer Center, Duluth, Minnesota 55805, United States
Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario L8V 5C2, Canada
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec G1R 2J6, Canada
CHUS-Hopital Fleurimont, Fleurimont, Quebec J1H 5N4, Canada
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 1999
Last updated: May 23, 2008
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