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Fallopian Tube CancerPhase 3NCT00004934

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 Phase 3 study testing carboplatin, epirubicin hydrochloride and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 18 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
carboplatin, epirubicin hydrochloride and paclitaxel
Type of treatment
Surgery or procedure
How many people
Not given
Where
18 sitesin 10 countries
Study dates
Aug 1999to May 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

18 sites in 10 countries.

18 sites in 10 countries

Canada5 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Italy3 sites

  • Spedali Civili

    Brescia, 25123

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Milano (Milan), 20133

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Denmark2 sites

  • Aalborg Hospital

    Aalborg, 9100

  • Odense University Hospital

    Odense, DK-5000

Other trials in Denmark

Portugal2 sites

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra, 3049

  • Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

    Lisbon, 1099-023 Codex

Other trials in Portugal

United States1 site

  • St. Mary's/Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

Other trials in United States

Belgium1 site

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

Israel1 site

  • Shaare Zedek Medical Center

    Jerusalem, 91031

Other trials in Israel

Netherlands1 site

  • Medisch Spectrum Twente

    Enschede, 7500 KA

Other trials in Netherlands

Norway1 site

  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

Spain1 site

  • Institut d'Oncologia Corachan

    Barcelona, 08.017

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
carboplatin, epirubicin hydrochloride, paclitaxel, conventional surgery
Keywords
stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 1999
  3. Study completionMay 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004934
Sponsor's protocol ID
CDR0000067620
Other IDs
NSGO-OC9804, CAN-NCIC-OV14, EORTC-55981
Status last verified
May 2003
First submitted
7 Mar 2000
Last updated
4 Feb 2013
Results posted
No

Publications

  • 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.

    PubMed 14656276

  • 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.

  • 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.

    PubMed 22539562

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, epirubicin hydrochloride and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 18 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Canada, Italy, Denmark, Portugal, United States and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004934, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.

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