Status:
UNKNOWN
Study on Decitabine Plus Carboplatin Versus Physician's Choice Chemotherapy in Recurrent, Platinum-resistant Ovarian Cancer.
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Recurrent, Platinum-resistant Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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, extraord...
Detailed Description
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 c...
Eligibility Criteria
Inclusion
- 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:
- Hematopoietic: Leukocytes \> 2,500/mm3; Absolute neutrophil count \>1,500/mm3; Platelets count \>100,000/mm3; Hemoglobin \>9 g/dL
- 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
- 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
- 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.
Key Trial Info
Start Date :
July 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03467178
Start Date
July 30 2018
End Date
December 1 2021
Last Update
September 5 2021
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy