|OV.18 (MRC ICON6) - A Randomised, Placebo-Controlled, Trial of Concurrent Cediranib [AZD2171] (with platinum-based chemotherapy) and Concurrent and Maintenance Cediranib in Women with Platinum-sensitive Relapsed Ovarian Cancer
OV.18 (MRC ICON6) was a randomized, three-arm, double-blind, placebo-controlled phase 3 trial that randomly assigned patients aged 18 years or older with relapsed platinum-sensitive ovarian cancer. Participants received up to six cycles of platinum-based chemotherapy (once every 3 weeks) then entered a maintenance phase. Participants were randomly allocated to receive placebo alongside chemotherapy and then placebo only maintenance (arm A), cediranib 20 mg once-daily alongside chemotherapy then placebo only maintenance (arm B), or cediranib 20 mg once-daily alongside chemotherapy then cediranib 20 mg once-daily maintenance (arm C).
Centres in Australia, Canada, New Zealand, Spain, and the UK enrolled 486 women between November 2007 and December 2011.
The results of the study showed that cediranib, when given orally with chemotherapy and continued as maintenance, yielded a meaningful improvement in progression-free survival in women with recurrent platinum-sensitive ovarian cancer, albeit with added toxic effects. The positive results in ICON6 could provide women with a new therapeutic option for recurrent ovarian cancer. Assessment of the secondary endpoint of overall survival will need longer follow-up.
Ledermann JA, Embleton AC, Raja F, Perren TJ, Jayson GC, Rustin GJS, Kaye SB, Hirte H, Eisenhauer E, Vaughan M, Friedlander M, Gonz?lez-Mart?n A, Stark D, Clark E, Farrelly L, Swart AM, Cook A, Kaplan RS, Parmar MKB. Cediranib in patients with relapsed platinum-sensitive ovarian cancer (ICON6): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet 387: 1066-74, 2016.
CO.17 - A Phase III Randomized Study of Cetuximab (Erbitux TM, C225) and Best Supportive Care versus Best Supportive Care in Patients with Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR) - Positive Colorectal Carcinoma
Liu G, Tu D, Lewis M, Cheng D, Sullivan LA, Chen Z, Morgen E, Simes J, Price TJ, Tebbutt NC, Shapiro JD, Jeffery GM, Mellor JD, Mikeska T, Virk S, Shepherd LE, Jonker DJ, O'Callaghan CJ, Zalcberg JR, Karapetis CS, Dobrovic A. Fc-y Receptor Polymorphisms, Cetuximab Therapy, and Survival in the NCIC CTG CO.17 Trial of Colorectal Cancer. Clin Cancer Res 22: 2435-44, 2016.
CO.21 - A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients with High Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial (CHALLENGE)
Courneya KS, Vardy JL, O'Callaghan CJ, Friedenreich CM, Campbell KL, Prapavessis H, Crawford JJ, O'Brien P, Dhillon HM, Jonker DJ, Chua NS, Lupichuk S, Sanatani MS, Gill S, Meyer RM, Begbie S, Bonaventura T, Burge ME, Turner J, Tu D, Booth CM. Effects of a Structured Exercise Program on Physical Activity and Fitness in Colon Cancer Survivors: One Year Feasibility Results from the CHALLENGE Trial (ONLINE). Cancer Epidemiol Biomarkers Prev 2016.
MA.17 - A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Liedke PER, Tu D, Shepherd L, Chavarri-Guerra Y, Pritchard KI, Stearns V, Goss PE. New onset vasomotor symptoms but not musculoskeletal symptoms associate with clinical outcomes on extended adjuvant letrozole - Analyses from NCIC CTG MA.17. The Breast 27: 99-104, 2016.
OV.16 - A Phase III Study of Cisplatin Plus Topotecan Followed by Paciltaxel plus Carboplatin versus Paclitaxel plus Carboplatin as First Line Chemotherapy in Women with Newly Diagnosed Advanced Epithelial Ovarian Cancer
Weberpals JI, Amin MS, Chen BE, Tu D, Spaans JN, Squire JA, Eisenhauer EA, Virk S, Ma D, Duciaume M, Hoskins P, LeBrun DP. First application of the Automated QUantitative Analysis (AQUA) technique to quantify PTEN protein expression in ovarian cancer: A correlative study of NCIC CTG OV.16. Gynecol Oncol 140: 486-93, 2016.
PA.3 - A Randomized Placebo Controlled Study of OSI-774 Plus Gemcitabine in Patients with Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Shultz DB, Pai J, Chiu W, Ng K, Hellendag MG, Heestand G, Chang DT, Tu D, Moore MJ, Parulekar WR, Koong AC. A Novel Biomarker Panel Examining Response to Gemcitabine with or without Erlotinib for Pancreatic Cancer Therapy in NCIC Clinical Trials Group PA.3. PLoS ONE 11: e0147995, 2016.
Zer A, Ding K, Lee SM, Goss GD, Seymour L, Ellis PM, Hackshaw A, Bradbury PA, Han L, O'Callaghan CJ, Tsao MS, Shepherd FA. Pooled Analysis of the Prognostic and Predictive Value of KRAS Mutation Status and Mutation Subtype in Patients with Non-Small Cell Lung Cancer Treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors. J Thoracic Oncol 11: 312-23, 2016