A Phase 2 interventional study of carboplatin and decitabine in Fallopian Tube Cancer, Ovarian Cancer and Peritoneal Cavity Cancer, sponsored by Cancer Research UK. Terminated at 11 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-10.
Sponsored by Cancer Research UK · Phase 2, Interventional, and Treatment
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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether carboplatin is more effective with or without decitabine in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
PURPOSE: This randomized phase II trial is studying carboplatin and decitabine to see how well they work compared with carboplatin alone in treating patients with progressive, advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to prior first-line treatment (platinum alone vs platinum and taxane vs platinum and other combination), WHO performance status (0 vs 1 vs 2), measurable disease criteria (RECIST criteria vs CA-125 criteria vs both), participating center, and the number of prior platinum-based regimens (1 vs 2). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for pharmacodynamic studies. Samples are assessed for methylation of hMLH1 by methylation-specific PCR; global DNA methylation by high performance liquid chromatography (HPLC) ; methylation of the MAGE-1A gene promoter by methylation-specific PCR or bisulfite pyrosequencing; and markers of apoptosis by ELISA. Pharmacokinetic studies of decitabine are also performed using blood samples from patients randomized to arm II. Ascitic fluid and/or tumor tissue samples may also be collected for pharmacodynamic studies.
After completion of study treatment, patients are followed at 28 days and then every 2 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 134 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Cancer Research UK is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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DISEASE CHARACTERISTICS:
Histologically or cytologically proven ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer
Previously treated with 1-2 prior platinum-containing regimen(s)
Disease relapse 6-12 months after completion of the most recent platinum-containing therapy
Measurable disease by RECIST criteria and/or CA-125 criteria
Ascites requiring therapeutic drainage allowed only if there is measurable disease by RECIST criteria
PATIENT CHARACTERISTICS:
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
No intolerance to carboplatin (with a dose of ≥ AUC 5), as defined by any of the following:
PRIOR CONCURRENT THERAPY:
Patients receive carboplatin IV over 30-60 minutes on day 1.
Drug: carboplatin
Patients receive decitabine IV over 6 hours on day 1 and carboplatin IV over 30-60 minutes on day 8.
Drug: carboplatin · Drug: decitabine
Given IV
Given IV
Response rate (partial response [PR] or complete response [CR]) in patients with methylated hMLH1 DNA in plasma as measured by RECIST criteria or CA-125 criteria
Response rate (PR or CR) in all patients (regardless of methylation status) as measured by RECIST criteria or CA-125 criteria
Progression-free survival and overall survival
Adverse events as measured by NCI CTCAE v3.0
Total dose and dose intensity of carboplatin and decitabine
Incidence of grade 3-4 hypersensitivity reactions
Correlation between peak plasma levels of decitabine and global and CpG island specific DNA methylation in peripheral blood mononuclear cells
Correlation between response (PR or CR) and global and CpG island specific DNA methylation in peripheral blood mononuclear cells
Correlation between response (PR or CR) and CpG island specific DNA methylation in plasma DNA
CpG island specific DNA methylation in plasma and tumor DNA
CpG island specific DNA methylation in tumor DNA and expression of genes as measured by RNA or protein assays
Correlation between response (PR, CR, or stable disease) and CpG island specific DNA methylation in tumor DNA and expression of genes by RNA or protein assays
Immunoassays of proteins in plasma
CpG island specific DNA methylation in tumor DNA
This study is terminated, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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