Condition category
Cancer
Date applied
18/05/2001
Date assigned
18/05/2001
Last edited
20/09/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctu.mrc.ac.uk/studies/ICON5.asp

Contact information

Type

Scientific

Primary contact

Dr P Harper

ORCID ID

Contact details

Medical Oncology
3rd Floor Thomas Guy House
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00011986

Protocol/serial number

E164/58

Study information

Scientific title

Acronym

ICON5/GOG182

Study hypothesis

To evaluate a variety of chemotherapy regimes for patients with advanced stage (FIGO III-IV) epithelial ovarian or serious primary peritoneal carcinoma. Efficacy will be determined through analysis of overall survival and progression free survival.

The trial will also compare the toxicities and adverse effects of each treatment regimen, describe the dose density and collative dose delivery for each regime, compare response rates in patients with measurable disease. In the UK, evaluate the impact of regimes on quality of life, evaluate the impact of regimes on resource use and quality-adjusted life-years, collect and store genetic material for future studies of molecular genetics.

The trial includes two stages, at the end of the first stage only those treatment arms that appear promising on the basis of progression free survival will continue in to the second stage which aims to evaluate the impact of the regimes on overall survival.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Ovarian cancer and peritoneal carcinoma

Intervention

Arm I: Taxol 175 mg/m^2 day one, Carboplatin AUC6 or AUC(EDTA)5 iv day one, eight cycles
Arm II: Taxol 175 mg/m^2, day one, Gemzar 800 mg/m^2 days one and eight, Carboplatin AUC5 or AUC(EDTA)4, day one, eight cycles
Arm III: Taxol 175 mg/m^2 day one, Caelyx 30 mg/m^2 day one every other cycle, Carboplatin AUC5 or AUC(EDTA)4 day one, eight cycles
Arm IV: Hycamtin 1.25 mg/m^2 days one, two and three, Carboplatin AUC5 or AUC(EDTA)4 day three, four cycles, then four cycles of Arm I
Arm V: Gemzar 1000 mg/m^2, days one and eight, Carboplatin AUC6 or AUC(EDTA)5 day eight, four cycles then four cycles of Arm I

In every case cycles are 21 days long. Chemotherapy continues unless disease progression or unacceptable toxicity occurs. Dose reductions or delays for toxicity are defined in the full protocol.

Intervention type

Drug

Phase

Not Applicable

Drug names

Carboplatin and paclitaxel

Primary outcome measures

Overall survival.

Secondary outcome measures

1. Progression free survival
2. Response rate (in patients with measurable disease)
3. Toxicity and symptoms
4. Dose and dose intensity
5. Patients assessment of quality of life and acceptability of treatment, health economics
6. Molecular genetics (future study)

Overall trial start date

01/03/2002

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Stage III or IV ovarian or serious primary peritoneal carcinoma, following appropriate surgery
2. Tumor tissue available for histological evaluation
3. Adequate bone marrow liver kidney and neurological function
4. World Health Organisation (WHO) performance status zero to two
5. Fit and able to take part in trial treatments and follow-up
6. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4000

Participant exclusion criteria

1. Concomitant or previous malignancies likely to interfere with protocol treatments
2. Patient has received radiotherapy or chemotherapy to any abdominal or pelvic tumour
3. Acute hepatitis, infection or Gastrointestinal bleeding
4. Women of childbearing age who will not use adequate contraception or are breastfeeding

Recruitment start date

01/03/2002

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United States of America

Trial participating centre

Medical Oncology
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results:
1. 2003 results: http://www.ncbi.nlm.nih.gov/pubmed/12927999
2. 2009 results: http://www.ncbi.nlm.nih.gov/pubmed/19224846

Publication citations

  1. Results

    Copeland LJ, Bookman M, Trimble E, , Clinical trials of newer regimens for treating ovarian cancer: the rationale for Gynecologic Oncology Group Protocol GOG 182-ICON5., Gynecol. Oncol., 2003, 90, 2 Pt 2, S1-7.

  2. Results

    Bookman MA, Brady MF, McGuire WP, Harper PG, Alberts DS, Friedlander M, Colombo N, Fowler JM, Argenta PA, De Geest K, Mutch DG, Burger RA, Swart AM, Trimble EL, Accario-Winslow C, Roth LM, Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: a Phase III Trial of the Gynecologic Cancer Intergroup., J. Clin. Oncol., 2009, 27, 9, 1419-1425, doi: 10.1200/JCO.2008.19.1684.

Additional files

Editorial Notes