Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate 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

Basic Trial Information

Objectives

1. 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.
2. Compare the toxicity of these 2 regimens in these patients.
3. Compare the quality of life of patients treated with these 2 regimens.

Entry Criteria

Disease Characteristics:

• Histologically proven stage IIB, III, or IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer

• No symptomatic brain metastasis

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• WHO/ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 800 patients will be accrued for this study.

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.

Kristensen GB, Vergote I, Stuart G, et al.: First-line treatment of ovarian cancer FIGO stages IIb-IV with paclitaxel/epirubicin/carboplatin versus paclitaxel/carboplatin. Int J Gynecol Cancer 13 (Suppl 2): 172-7, 2003 Nov-Dec.[PUBMED Abstract]

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 phase III trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-805, 2002.

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 NCIC CTG. Results on progression-free survival. [Abstract] Int J Gynecol Cancer 15 (Suppl 3): 221, 2005.

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 NCIC CTG. Results on progression free survival. [Abstract] J Clin Oncol 22 (Suppl 14): A-5003, 449s, 2004.

Trial Contact Information

Trial Lead Organizations

Nordic Society for Gynaecologic Oncology

Gunnar Kristensen, MD, PhD, Protocol chair		Ph: 47-2293-4000 Email: gunnar.kristensen@klinmed.uio.no

European Organization for Research and Treatment of Cancer

Ignace Vergote, MD, PhD, Protocol chair		Ph: 31-16-344-635

NCIC-Clinical Trials Group

Gavin Stuart, MD, Protocol chair		Ph: 403-944-1721 Email: gavinst@cancerboard.ab.ca

Registry Information
Official Title		A Randomized Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) versus Paclitaxel/Carboplatin (TC) in the Treatment of Women with Advanced Ovarian Cancer
Trial Start Date		1999-08-27
Registered in ClinicalTrials.gov		NCT00004934
Date Submitted to PDQ		2000-01-13
Information Last Verified		2003-05-29

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