Carboplatin With or Without Decitabine in Treating Patients With Progressive, Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

NCT00748527 | Terminated Phase 2

• 5 other identifiers: CRUK-PH2/051CDR0000613805EUDRACT-2006-002324-41MGI-CRUK-PH2/051CTA-21106/0219/001
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 11

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. 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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

fallopian tube cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; peritoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• 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

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients receive carboplatin IV over 30-60 minutes on day 1.

Drug: carboplatin

Arm II

EXPERIMENTAL

Patients receive decitabine IV over 6 hours on day 1 and carboplatin IV over 30-60 minutes on day 8.

Drug: carboplatin; Drug: decitabine

Interventions

carboplatin DRUG

Given IV

Arm I; Arm II

decitabine DRUG

Given IV

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (11)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Hammersmith Hospital

London, England, W12 OHS, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Weston General Hospital

Weston-super-Mare, England, BS23 4TQ, United Kingdom

Location

Belfast City Hospital Trust Incorporating Belvoir Park Hospital

Belfast, Northern Ireland, BT8 8JR, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Decitabine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Azacitidine; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Stanley B. Kaye, MD, FRCP

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: November 1, 2010
• Last Updated: July 10, 2013

Record last verified: 2008-09

Locations

GB (11)