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A Randomized Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) Versus Paclitaxel/Carboplatin (TC) in the Treatment of Women With Advanced Ovarian Cancer


Phase 3
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Randomized Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) Versus Paclitaxel/Carboplatin (TC) in the Treatment of Women With Advanced Ovarian 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Gunnar B. Kristensen, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Norwegian Radium Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067620

NCT ID:

NCT00004934

Start Date:

August 1999

Completion Date:

May 2003

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

St. Mary's/Duluth Clinic Cancer CenterDuluth, Minnesota  55805-1983