Status:
TERMINATED
Carboplatin With or Without Decitabine in Treating Patients With Progressive, Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Lead Sponsor:
Cancer Research UK
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givi...
Detailed Description
OBJECTIVES: Primary * To compare the response rate in patients with progressive, advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who have methylated hMLH1 DNA...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically proven ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer
- Progressive disease as defined by RECIST criteria and/or CA-125 criteria
- Advanced disease
- Previously treated with 1-2 prior platinum-containing regimen(s)
- Prior hormonal therapy does not count towards the prior treatment
- Responded to the most recent prior platinum-containing regimen(s) OR no evidence of progression during platinum-containing therapy as documented by RECIST criteria or CA-125 criteria (for patients with no macroscopic residual disease after surgery who are not evaluable by CA-125)
- Disease relapse 6-12 months after completion of the most recent platinum-containing therapy
- Patients who received two prior lines of treatment must have had ≥ 6 months between their first and second lines of treatment
- Patients with disease progression, as defined by CA-125 criteria alone, within 6 months after completion of their last treatment are eligible provided study treatment commences \> 6 months after the last prior treatment
- Patients with disease progression, as defined by GCIG guidelines, within 12 months after completion of their last treatment are eligible provided study treatment commences ≤ 14 months after the last prior treatment
- Measurable disease by RECIST criteria and/or CA-125 criteria
- Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques (physical examination, CT scan, x-ray, or MRI) or as ≥ 10 mm by spiral CT scan
- Patients with evaluable disease by CA-125 criteria are eligible provided CA-125 is ≥ 2 times upper limit of normal (ULN) within 2 weeks prior to initiating study treatment
- Disease is not considered measurable if patient received prior mouse antibodies or if there has been medical and/or surgical interference with the peritoneum or pleura (e.g., paracentesis) within the past 28 days
- Ascites requiring therapeutic drainage allowed only if there is measurable disease by RECIST criteria
- Ascites that do not require therapeutic drainage allowed even if disease is evaluable by CA-125 criteria alone
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Hemoglobin ≥ 10.0 g/dL
- WBC ≥ 3.0 x 10\^9/L
- Neutrophil count ≥ 1.5 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L
- Bilirubin ≤ 30 μmol/L
- ALT and/or AST ≤ 2.5 times ULN (≤ 5 times ULN if due to tumor involvement of liver)
- EDTA/DTPA clearance ≥ 50 mL/min (uncorrected value)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 4 weeks prior to, during, and for 6 months after completion of study treatment
- No known hepatitis B, hepatitis C, or HIV positivity
- No non-malignant systemic disease, including active uncontrolled infection, that would make the patient a high medical risk
- No other current malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
- Patients who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for ≥ 5 years and the patient is deemed to be at low risk for recurrence
- No intolerance to carboplatin (with a dose of ≥ AUC 5), as defined by any of the following:
- Neutropenia or thrombocytopenia causing dose delay of \> 4 days on more than 2 occasions
- Grade III or IV hypersensitivity reaction (not controlled by a desensitization regimen)
- Hospitalization for confirmed febrile neutropenia (fever ≥ 38°C)
- Requirement for platelet transfusion
- No other condition that, in the investigator's opinion, would not make the patient a good candidate for this study
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy (alopecia, grade 1 neuropathy, and certain grade 1 toxicities allowed)
- More than 28 days since prior maintenance therapy (e.g., erlotinib or bevacizumab)
- More than 4 weeks since prior radiotherapy, endocrine therapy, immunotherapy, chemotherapy, biological therapy, or investigational agents
- More than 4 weeks since prior major thoracic and/or abdominal surgery and recovered
- No other concurrent anti-cancer therapy, including radiotherapy or investigational drugs
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00748527
Start Date
July 1 2007
End Date
November 1 2010
Last Update
July 10 2013
Active Locations (11)
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1
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
2
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
3
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
4
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ