Brief Title
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
Official Title
A Randomized Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) Versus Paclitaxel/Carboplatin (TC) in the Treatment of Women With Advanced Ovarian Cancer
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.
Study Phase
Phase 3
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
August 1999
Completion Date
May 2003
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gunnar B. Kristensen, MD, PhD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT00004934
Organization ID
CDR0000067620
Secondary IDs
NSGO-OC9804
Study Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor
Gunnar B. Kristensen, MD, PhD, Study Chair, Norwegian Radium Hospital
Verification Date
May 2003