ICON8: Weekly Chemotherapy in Ovarian Cancer

This study is currently recruiting participants.
Verified July 2012 by Medical Research Council
Sponsor:
Collaborator:
Clinical Trials Awards and Advisory Committee
Information provided by (Responsible Party):
Medical Research Council
ClinicalTrials.gov Identifier:
NCT01654146
First received: June 20, 2012
Last updated: July 26, 2012
Last verified: July 2012

June 20, 2012
July 26, 2012
June 2011
June 2017   (final data collection date for primary outcome measure)
  • Stage 1: Feasibility assessed as the number of cycles and dose intensity of protocol treatment delivered per patient. [ Time Frame: 6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm ] [ Designated as safety issue: No ]
  • Stage 1: Safety assessed as the rate of any ≥ grade 3 toxicity experienced per patient. [ Time Frame: 6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm ] [ Designated as safety issue: Yes ]
  • Stage 2: Progression Free Survival rate at 9 months after randomisation [ Time Frame: 9 months after first 62 patients randomised per arm ] [ Designated as safety issue: No ]
  • Stage 3: Progression Free Survival [ Time Frame: PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised. ] [ Designated as safety issue: No ]
  • Stage 3: Overall Survival [ Time Frame: PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01654146 on ClinicalTrials.gov Archive Site
  • Stage 3: Toxicity assessed by number of participants with adverse events [ Time Frame: Expected 1 year and 3 years after last patient is randomised. ] [ Designated as safety issue: No ]
    Assessment of toxicity profile of dose-fractionated chemotherapy
  • Stage 3: Quality of Life [ Time Frame: Expected 1 year and 3 years after last patient is randomised. ] [ Designated as safety issue: No ]
    Assessment of potential impact of dose-fractionated chemotherapy on functionality and well-being in patients undergoing first line treatment for ovarian cancer.
  • Stage 3: Health Economics [ Time Frame: Expected 1 year and 3 years after last patient is randomised. ] [ Designated as safety issue: No ]
    Cost-effectiveness analysis of dose-fractionated chemotherapy
Same as current
Not Provided
Not Provided
 
ICON8: Weekly Chemotherapy in Ovarian Cancer
An International Phase III Randomised Trial of Dose Fractionated Chemotherapy Compared to Standard Three Weekly Chemotherapy, Following Immediate Primary Surgery or as Part of Delayed Primary Surgery, for Women With Newly Diagnosed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or carboplatin at a lower dose every week) is more effective than standard chemotherapy (paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian cancer. The investigators also want to see if weekly chemotherapy causes more or fewer side-effects than standard chemotherapy.

ICON8 is a three-arm, three stage trial. Patients will be randomised in a 1:1:1 ratio. Patients in arm 1 (control arm) will receive weekly carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles. Patients in arm 2 will receive carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles. Patients in arm 3 will receive dose-fractionated weekly carboplatin and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.

The trial will have three planned stages. Stage 1 will be conducted to confirm feasibility and safety of protocol treatment in all patients and separately in the Delayed Primary Surgery (DPS) patients. The outcome measure for stage 2 will be 9-month progression-free survival (PFS) rate. The primary outcome measures for stage 3 will be PFS and overall survival and secondary outcomes will be toxicity, Quality of Life and Health Economics. If pre-defined levels of deliverability, at stage 1, or activity, at stage 2, are not met then the research arms will be reconsidered.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: Carboplatin
    AUC5 by intravenous infusion over 30-60 minutes
  • Drug: Carboplatin
    AUC2 by intravenous infusion over 30-60 minutes
  • Drug: Paclitaxel
    175mg/m2 by intravenous infusion over 3 hours
  • Drug: Paclitaxel
    80mg/m2 by intravenous infusion over 1 hour
  • Active Comparator: Arm 1 (Control Arm)
    Carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: Arm 2 (Research arm)
    Carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: Arm 3 (Research arm)
    Dose-fractionated weekly carboplatin and weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1485
Not Provided
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Females aged 18 years or more
  • Signed informed consent and ability to comply with the protocol
  • Histologically confirmed, with core biopsy from a disease site as minimum requirement (cytology alone is insufficient for diagnosis):

    • Epithelial ovarian carcinoma
    • Primary peritoneal carcinoma of Müllerian histological type
    • Fallopian tube carcinoma
  • FIGO stage IC or above, which may be based on clinical and radiological assessment in patients who have not undergone immediate primary surgery
  • Confirmed high-risk histological subtype for patients with FIGO stage IC/IIA disease, namely:

    • High grade serous carcinoma
    • Clear cell carcinoma
    • Other histological subtype considered poorly differentiated/grade 3
  • ECOG Performance Status (PS) 0-2
  • Life expectancy > 12 weeks
  • Adequate bone marrow function:

    • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/l
    • Platelets (Plt) ≥ 100 x 109/l
    • Haemoglobin (Hb) ≥ 9g/dl (can be post transfusion)
  • Adequate liver function (within 28 days prior to randomisation):

    • Serum bilirubin (BR) ≤ 1.5 x ULN
    • Serum transaminases ≤ 3 x ULN in the absence of parenchymal liver metastases or ≤ 5 x ULN in the presence of parenchymal liver metastases
  • Adequate renal function as defined by GFR (Glomerular Filtration Rate) ≥ 30ml/min.

Exclusion Criteria:

  • Non-epithelial ovarian cancer, including malignant mixed Müllerian tumours (carcinosarcomas)
  • Peritoneal cancer that is not of Müllerian origin, including mucinous histology
  • Borderline tumours (tumours of low malignant potential)
  • Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
  • Previous malignancies within 5 years prior to randomisation apart from: adequately treated carcinoma in-situ of the cervix, breast ductal carcinoma in-situ, non-melanomatous skin cancer; or previous/synchronous early-stage endometrial cancer defined as stage IA (FIGO 2009) grade 1 or 2 endometrioid cancers with no lymphovascular space invasion
  • Pre-existing sensory or motor neuropathy grade ≥ 2
  • Evidence of any other disease/metabolic dysfunction that in the opinion of the investigator would put the subject at high-risk of treatment-related complications or prevent compliance with the trial protocol
  • Planned intraperitoneal cytotoxic chemotherapy
  • Any previous radiotherapy to the abdomen or pelvis
  • Sexually active women of childbearing potential not willing to use adequate contraception (e.g. oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least six months afterwards
  • Pregnant or lactating women
  • Treatment with any other investigational agent prior to protocol defined progression
  • Known hypersensitivity to carboplatin, paclitaxel or their excipients (including cremophor)
  • History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory in the case of suspected brain metastases. Spinal MRI is mandatory in the case of suspected spinal cord compression. Patients with brain or meningeal metastases are not eligible
Female
18 Years and older
No
Not Provided
United Kingdom
 
NCT01654146
2010-022209-16, 10356387
Yes
Medical Research Council
Medical Research Council
Clinical Trials Awards and Advisory Committee
Not Provided
Medical Research Council
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP