A Phase 2 interventional study of Decitabine and Carboplatin in Recurrent, Platinum-resistant Ovarian Cancer, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Status unknown at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Phase 2, Interventional, and Treatment
Multicenter Phase II study on Decitabine-Carboplatin combination in platinum resistant ovarian cancer patients.
Patients will receive study treatment until disease progression is documented, extraordinary medical circumstances occur, intolerable toxicities occur, or the patient withdraws consent.
This is an open-label, prospective, multicenter, randomized Phase II, clinical trial evaluating the efficacy and safety of Decitabine-Carboplatin combination in recurrent, platinum resistant ovarian cancer patients in comparison to physician' choice chemotherapy:
Arm A: Carboplatin AUC (Area Under Curve) 5 d 8 q 28 Plus Decitabine 10 mg/mq iv d1-5 q 28
Arm B: Pegylated Liposomal Doxorubicin 40 mg/mq q 28 or Gemcitabine 1000 mg/mq dd 1, 8, 15 q 28 or Weekly Paclitaxel 80 mg/mq gg 1, 8, 15 q 28
Patients will be randomly assigned in a 1:1 ratio to treatment arms.
Adequate organ functions:
Hepatic: AST (aspartate transaminase ) and ALT (alanine transaminase) \<3 times upper limit of normal (ULN)*; Alkaline phosphatase \<3 times ULN*; Bilirubin \<1.5 times ULN
*: \<5 times ULN if liver metastases are present
Exclusion Criteria:
Carboplatin AUC 5 d 8 q 28 plus Decitabine 10 mg/mq iv d1-5 q 28
Drug: Decitabine · Drug: Carboplatin
Pegylated Liposomal Doxorubicin 40 mg/mq q 28 or Gemcitabine 1000 mg/mq dd 1, 8, 15 q 28 or Weekly Paclitaxel 80 mg/ m2 dd 1, 8, 15 q 28
Drug: Pegylated Liposomal Doxorubicin · Drug: Gemcitabine · Drug: Paclitaxel
Nucleic Acid Synthesis Inhibitor
Chemotherapy medication
Chemotherapy medication
Chemotherapy medication
Chemotherapy medication
Progression free survival (PFS)
The primary objective is to compare Decitabine plus Carboplatin combination versus physician' choice chemotherapy in terms of progression free survival
Time frame: from randomization to the date of radiological/clinical progression of disease or death, assessed up to 3 years
Overall survival (OS)
The secondary objective is to compare Decitabine plus Carboplatin combination versus physician' choice chemotherapy in terms of overall survival
Time frame: from randomization to the date of death, assessed up to 3 years
Radiological response rate (in patients with measurable disease)
Radiological response rate
Time frame: 3 years
Duration of response
Duration of response
Time frame: 3 years
Cancer-Antigen 125 (CA-125) response rate per GCIG (Gynaecologic Cancer Intergroup) and change in CA-125
Serum level of CA125 is used to monitor response to chemotherapy, relapse, and disease progression in ovarian cancer patients.
Time frame: 3 years
Toxicity profile
Incidence of adverse events
Time frame: 3 years
Patient Reported Outcome: Physical well-being
will be evaluated using the Functional Assessment of Cancer Therapy (FACT-O) and FACT-O Ovarian Cancer-specific Subscale (OCS) questionnaire. The total scores of both scales will be calculated, the scores of each question at each time point and their difference from baseline will be summarized for each treatment group. At a given visit, the change and/or percent change from baseline will be compared between the randomized treatment groups using an ANCOVA test using the treatment as a categorical factor and baseline measurement for the parameter as a continuous covariate. The time to an event in PRO (Patient Reported Outcome) of worsening of disease symptoms will be defined as the time from randomization to a 4-point reduction in the FACT-O questionnaire. Patients without a 4-point reduction will be censored on the date of their last PRO evaluation. Patients that do not have both a baseline measurement and at least one post-baseline measurement will not be included.
Time frame: 3 years
Patient Reported Outcome: Social/family well-being
will be evaluated using the Functional Assessment of Cancer Therapy (FACT-O) and FACT-O ovarian cancer-specific subscale (OCS) questionnaire. The total scores of both scales will be calculated, the scores of each question at each time point and their difference from baseline will be summarized for each treatment group. At a given visit, the change and/or percent change from baseline will be compared between the randomized treatment groups using an ANCOVA test using the treatment as a categorical factor and baseline measurement for the parameter as a continuous covariate. The time to an event in PRO of worsening of disease symptoms will be defined as the time from randomization to a 4-point reduction in the FACT-O questionnaire. Patients without a 4-point reduction will be censored on the date of their last PRO evaluation. Patients that do not have both a baseline measurement and at least one post-baseline measurement will not be included.
Time frame: 3 years
Patient Reported Outcome: Functional well being
will be evaluated using the Functional Assessment of Cancer Therapy (FACT-O) and FACT-O ovarian cancer-specific subscale (OCS) questionnaire. The total scores of both scales will be calculated, the scores of each question at each time point and their difference from baseline will be summarized for each treatment group. At a given visit, the change and/or percent change from baseline will be compared between the randomized treatment groups using an ANCOVA test using the treatment as a categorical factor and baseline measurement for the parameter as a continuous covariate. The time to an event in PRO of worsening of disease symptoms will be defined as the time from randomization to a 4-point reduction in the FACT-O questionnaire. Patients without a 4-point reduction will be censored on the date of their last PRO evaluation. Patients that do not have both a baseline measurement and at least one post-baseline measurement will not be included.
Time frame: 3 years
Patient Reported Outcome: Emotional well being
will be evaluated using the Functional Assessment of Cancer Therapy (FACT-O) and FACT-O ovarian cancer-specific subscale (OCS) questionnaire. The total scores of both scales will be calculated, the scores of each question at each time point and their difference from baseline will be summarized for each treatment group. At a given visit, the change and/or percent change from baseline will be compared between the randomized treatment groups using an ANCOVA test using the treatment as a categorical factor and baseline measurement for the parameter as a continuous covariate. The time to an event in PRO of worsening of disease symptoms will be defined as the time from randomization to a 4-point reduction in the FACT-O questionnaire. Patients without a 4-point reduction will be censored on the date of their last PRO evaluation. Patients that do not have both a baseline measurement and at least one post-baseline measurement will not be included.
Time frame: 3 years
Plan to share: No
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano