Study on Decitabine Plus Carboplatin Versus Physician's Choice Chemotherapy in Recurrent, Platinum-resistant Ovarian Cancer.

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Treatments: Azacitidine; Carboplatin; Decitabine; Doxorubicin; Gemcitabine; Liposomal doxorubicin; Paclitaxel

Criteria

Inclusion Criteria:

• Cytologic / histologic diagnosis of stage 1°C-4° epithelial , fallopian tube and primary peritoneal cancer (carcinosarcomas are included)

• Patient who received 1-2 prior lines of treatments

• Patient relapsed within 6 months after platinum containing regimen

• Disease measurable or evaluable by RECIST version 1.1 or Ca 125 GCIG criteria (Gynaecologic Cancer Intergroup).

• No residual peripheral neurotoxicity > Grade 1 from previous chemotherapy treatment

• Performance Status (PS) 0-1

• Age 18 years.

• Life expectancy of at least 3 months

• Written informed consent prior to performance of study specific procedures or assessments

• Ability and willingness to comply with treatment and follow up assessments and procedures

• Adequate organ functions:

1. Hematopoietic: Leukocytes > 2,500/mm3; Absolute neutrophil count >1,500/mm3; Platelets count >100,000/mm3; Hemoglobin >9 g/dL

2. 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

3. Renal: Creatinine clearance >45 mL/min

• No other invasive malignancy within the past 3 years except non-melanoma skin cancer and in situ cervical cancer

• Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule.

Exclusion Criteria:

• Pregnant (potentially fertile patients must use contraceptive measures to avoid pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test at baseline).

• Patients should not be breast-feeding during treatment and for 2 months following the end of treatment.

• Serious heart disease, including heart failure, atrio-ventricular block of any degree, serious arrhythmia or history of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)

• Active infection requiring antibiotics.

• History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months

• History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.

• Patients who had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with < Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.

• Patients with evidence of interstitial lung disease.

• Major surgical procedure, open biopsy, or significant traumatic injury within 3 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded.

• Known hypersensitivity to the study drugs or to drugs with similar chemical structures.

• Concurrent treatment with other experimental drugs.

• Participation in another clinical trial with any investigational drug within 30 days prior to study screening.