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

This study has been completed.
Sponsor:
Collaborators:
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004934
First received: March 7, 2000
Last updated: February 1, 2013
Last verified: May 2003

March 7, 2000
February 1, 2013
August 1999
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Complete list of historical versions of study NCT00004934 on ClinicalTrials.gov Archive Site
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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
A Randomized Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) Versus Paclitaxel/Carboplatin (TC) in the Treatment of Women With Advanced Ovarian Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Drug: carboplatin
  • Drug: epirubicin hydrochloride
  • Drug: paclitaxel
  • Procedure: conventional surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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May 2003
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Denmark,   Israel,   Italy,   Netherlands,   Norway,   Portugal,   Spain
 
NCT00004934
CDR0000067620, NSGO-OC9804, CAN-NCIC-OV14, EORTC-55981
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Nordic Society for Gynaecologic Oncology
  • European Organisation for Research and Treatment of Cancer - EORTC
  • NCIC Clinical Trials Group
Study Chair: Gunnar B. Kristensen, MD, PhD Norwegian Radium Hospital
Study Chair: Ignace B. Vergote, MD, PhD U.Z. Gasthuisberg
Study Chair: Gavin C.E. Stuart, MD Tom Baker Cancer Centre - Calgary
National Cancer Institute (NCI)
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP