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NCT01654146 · CITED IN SOURCE DOCUMENTS

ICON8: Weekly Chemotherapy in Ovarian Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2012-07-31

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles
    intervention Names
    1. Drug: Carboplatin
    2. Drug: Paclitaxel
    label
    Arm 1 (Control Arm)
    type
    ACTIVE_COMPARATOR
  2. description
    Carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles
    intervention Names
    1. Drug: Carboplatin
    2. Drug: Paclitaxel
    label
    Arm 2 (Research arm)
    type
    EXPERIMENTAL
  3. description
    Dose-fractionated weekly carboplatin and weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.
    intervention Names
    1. Drug: Carboplatin
    2. Drug: Paclitaxel
    label
    Arm 3 (Research arm)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm 1 (Control Arm)
    2. Arm 2 (Research arm)
    description
    AUC5 by intravenous infusion over 30-60 minutes
    name
    Carboplatin
    type
    DRUG
  2. arm Group Labels
    1. Arm 3 (Research arm)
    description
    AUC2 by intravenous infusion over 30-60 minutes
    name
    Carboplatin
    type
    DRUG
  3. arm Group Labels
    1. Arm 1 (Control Arm)
    description
    175mg/m2 by intravenous infusion over 3 hours
    name
    Paclitaxel
    type
    DRUG
  4. arm Group Labels
    1. Arm 2 (Research arm)
    2. Arm 3 (Research arm)
    description
    80mg/m2 by intravenous infusion over 1 hour
    name
    Paclitaxel
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1485
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. 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
  2. measure
    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
  3. measure
    Stage 2: Progression Free Survival rate at 9 months after randomisation
    time Frame
    9 months after first 62 patients randomised per arm
  4. measure
    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.
  5. measure
    Stage 3: Overall Survival
    time Frame
    PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.
secondary Outcomes
  1. description
    Assessment of toxicity profile of dose-fractionated chemotherapy
    measure
    Stage 3: Toxicity assessed by number of participants with adverse events
    time Frame
    Expected 1 year and 3 years after last patient is randomised.
  2. description
    Assessment of potential impact of dose-fractionated chemotherapy on functionality and well-being in patients undergoing first line treatment for ovarian cancer.
    measure
    Stage 3: Quality of Life
    time Frame
    Expected 1 year and 3 years after last patient is randomised.
  3. description
    Cost-effectiveness analysis of dose-fractionated chemotherapy
    measure
    Stage 3: Health Economics
    time Frame
    Expected 1 year and 3 years after last patient is randomised.
Full study description
brief Summary
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.
detailed Description
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.
Source references
references
  1. citation
    Colomban O, Clamp A, Cook A, McNeish IA, You B. Benefit From Fractionated Dose-Dense Chemotherapy in Patients With Poor Prognostic Ovarian Cancer: ICON-8 Trial. JCO Clin Cancer Inform. 2023 Apr;7:e2200188. doi: 10.1200/CCI.22.00188.
    pmid
    37075255
    type
    DERIVED
  2. citation
    Clamp AR, James EC, McNeish IA, Dean A, Kim JW, O'Donnell DM, Gallardo-Rincon D, Blagden S, Brenton J, Perren TJ, Sundar S, Lord R, Dark G, Hall M, Banerjee S, Glasspool RM, Hanna CL, Williams S, Scatchard KM, Nam H, Essapen S, Parkinson C, McAvan L, Swart AM, Popoola B, Schiavone F, Badrock J, Fananapazir F, Cook AD, Parmar M, Kaplan R, Ledermann JA. Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment (ICON8): overall survival results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2022 Jul;23(7):919-930. doi: 10.1016/S1470-2045(22)00283-2. Epub 2022 Jun 9.
    pmid
    35690073
    type
    DERIVED
  3. citation
    Morgan RD, McNeish IA, Cook AD, James EC, Lord R, Dark G, Glasspool RM, Krell J, Parkinson C, Poole CJ, Hall M, Gallardo-Rincon D, Lockley M, Essapen S, Summers J, Anand A, Zachariah A, Williams S, Jones R, Scatchard K, Walther A, Kim JW, Sundar S, Jayson GC, Ledermann JA, Clamp AR. Objective responses to first-line neoadjuvant carboplatin-paclitaxel regimens for ovarian, fallopian tube, or primary peritoneal carcinoma (ICON8): post-hoc exploratory analysis of a randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):277-288. doi: 10.1016/S1470-2045(20)30591-X. Epub 2020 Dec 22.
    pmid
    33357510
    type
    DERIVED
  4. citation
    Blagden SP, Cook AD, Poole C, Howells L, McNeish IA, Dean A, Kim JW, O'Donnell DM, Hook J, James EC, White IR, Perren T, Lord R, Dark G, Earl HM, Hall M, Kaplan R, Ledermann JA, Clamp AR. Weekly platinum-based chemotherapy versus 3-weekly platinum-based chemotherapy for newly diagnosed ovarian cancer (ICON8): quality-of-life results of a phase 3, randomised, controlled trial. Lancet Oncol. 2020 Jul;21(7):969-977. doi: 10.1016/S1470-2045(20)30218-7.
    pmid
    32615110
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        her rate of grade 3 or 4 anemia (36% vs. 16%) and grade 2 to 4 sensory neuropathy (26% vs. 18%).</li></ul></div></li><li>The phase III <a href="/clinicaltrials/NCT01654146">ICON8</a> (NCT01654146) trial compared weekly paclitaxel with every-3-week dosing, with another arm that compared weekly paclitaxel with weekly carboplatin (A
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        anemia (36% vs. 16%) and grade 2 to 4 sensory neuropathy (26% vs. 18%).</li></ul></div></li><li>The phase III <a href="/clinicaltrials/NCT01654146">ICON8</a> (NCT01654146) trial compared weekly paclitaxel with every-3-week dosing, with another arm that compared weekly paclitaxel with weekly carboplatin (AUC, 2 &#739; 6 cycles).[
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        </td> </tr> <tr> <td rowspan="3"> <strong> <a href="/clinicaltrials/NCT01654146">ICON8</a> </strong> [<a href="#cit/section_7.29">29</a>,<a href="#cit/section_7.31">31</a>] </td>
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      source title
      Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice