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

NCT00004934 | Completed Phase 3

• 4 other identifiers: CDR0000067620NSGO-OC9804CAN-NCIC-OV14EORTC-55981
• Study Type: interventional
• Target: N/A
• Locations: 10 countries
• Sites: 18

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer

Interventions

carboplatin DRUG

epirubicin hydrochloride DRUG

paclitaxel DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nordic Society of Gynaecological Oncology - Clinical Trials Unit: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• NCIC Clinical Trials Group: collaborator

Study Sites (18)

St. Mary's/Duluth Clinic Cancer Center

Duluth, Minnesota, 55805, United States

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Aalborg Hospital

Aalborg, 9100, Denmark

Location

Odense University Hospital

Odense, DK-5000, Denmark

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Spedali Civili

Brescia, 25123, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milano (Milan), 20133, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3049, Portugal

Location

Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

Lisbon, 1099-023 Codex, Portugal

Location

Institut d'Oncologia Corachan

Barcelona, 08.017, Spain

Location

Related Publications (5)

• Kristensen GB, Vergote I, Stuart G, Del Campo JM, Kaern J, Lopez AB, Eisenhauer E, Aavall-Lundquist E, Ridderheim M, Havsteen H, Mirza MR, Scheistroen M, Vrdoljak E. First-line treatment of ovarian cancer FIGO stages IIb-IV with paclitaxel/epirubicin/carboplatin versus paclitaxel/carboplatin. Int J Gynecol Cancer. 2003 Nov-Dec;13 Suppl 2:172-7. doi: 10.1111/j.1525-1438.2003.13363.x.

  PMID: 14656276 RESULT

• 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.

  RESULT

• Lindemann K, Christensen RD, Vergote I, Stuart G, Izquierdo MA, Kaern J, Havsteen H, Eisenhauer E, Ridderheim M, Lopez AB, Hirte H, Aavall-Lundquvist E, Vrdoljak E, Green J, Kristensen GB. First-line treatment of advanced ovarian cancer with paclitaxel/carboplatin with or without epirubicin (TEC versus TC)--a gynecologic cancer intergroup study of the NSGO, EORTC GCG and NCIC CTG. Ann Oncol. 2012 Oct;23(10):2613-2619. doi: 10.1093/annonc/mds060. Epub 2012 Apr 26.

  PMID: 22539562 RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Epirubicin; Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Gunnar B. Kristensen, MD, PhD

  Norwegian Radium Hospital

  STUDY CHAIR

• Ignace B. Vergote, MD, PhD

  University Hospital, Gasthuisberg

  STUDY CHAIR

• Gavin C.E. Stuart, MD

  Tom Baker Cancer Centre - Calgary

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 1999
• Study Completion: May 1, 2003
• Last Updated: February 4, 2013

Record last verified: 2003-05

Locations

NL (1); ES (1); PT (2); US (1); IL (1); IT (3); DK (2); CA (5); BE (1); NO (1)