Cediranib 20mg tablet OD (5 days out of 7) and Olaparib 300mg tablet BD (continuous) + standard of care

Placebo Cediranib 20mg tablet OD (5 days out of 7) and Placebo Olaparib 300mg tablet BD (continuous) + standard of care

Cervical Cancer

patients are eligible if diagnosed with cervical cancer

Cediranib film coated tablet, Olaparib film coated tablet

Cediranib, Olaparib

Clatterbridge Cancer Centre

A Phase II Clinical Trial of Cediranib and Olaparib Maintenance in Advanced Recurrent Cervical Cancer

A Randomised Double Blind Placebo Controlled Phase II Clinical Trial of Cediranib and Olaparib Maintenance in Advanced Recurrent Cervical Cancer (COMICE)

Date of disease progression
*Current standard of care in this group of patients would be clinical follow up with no treatment

Safety (Toxicity, Serious Adverse Events)

Functional Assessment of Cancer Therapy- Cervical Cancer questionnaire

The Clatterbridge Cancer Centre NHS Foundation Trust

University of Liverpool

Patients are randomised 1:1 to either placebo Cediranib and Olaparib or active Cediranib and Olaparib

COMICE is a double blind trial, the Investigator, Patient, Hospital Staff, Pharmacy and the COMICE trial team (Chief Investigator, Monitor, Trial Coordinator) are blinded to the treatment allocation

Leftover tissue from diagnostic procedures and/or surgery is cryopreserved and banked. Blood and/or bone marrow are also collected and banked. Cell lines are established and characterized via reverse-transcriptase polymerase chain reaction and/or flow cytometry for biomarkers and by DNA fingerprinting. Markers to be identified may include the following:
NEUROBLASTOMA: tyrosine hydroxylase, protein gene product (PGP) 9.5, GD2, HLA class I, and HSAN 1.2 antigens EWING FAMILY OF TUMORS: EWS-FLI1, EWS-ERG, and PGP 9.5 RETINOBLASTOMA: interphotoreceptor retinoid-binding protein ACUTE LYMPHOBLASTIC LEUKEMIA: immunophenotype ALVEOLOR RHADOMYOSARCOMA: PAX3-FKHR, PAX7-FKHR, and MyoD1 ALL CELL TYPES: telomerase expression including hTR and hTERTMutations of TP53 gene are detected by flow cytometry and/or immunocytochemistry

Lelftover tissue from diagnostic procedures and/or surgery, blood and bone marrow samples

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Central Nervous System Neoplasm

Ewing Sarcoma

Germ Cell Tumor

Leukemia

Lymphoma

Malignant Neoplasm

Neuroblastoma

Osteosarcoma

Retinoblastoma

Rhabdoid Tumor

Rhabdomyosarcoma

Soft Tissue Sarcoma

Cytology Specimen Collection Procedure

Laboratory Biomarker Analysis

Children's Hospital of Alabama

University of Alabama at Birmingham Cancer Center

Arkansas Children's Hospital

University of Arkansas for Medical Sciences

Kaiser Permanente Downey Medical Center

City of Hope Comprehensive Cancer Center

Miller Children's and Women's Hospital Long Beach

Children's Hospital Los Angeles

Children's Hospital and Research Center at Oakland

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Connecticut Children's Medical Center

MedStar Georgetown University Hospital

Lee Memorial Health System

Golisano Children's Hospital of Southwest Florida

Johns Hopkins All Children's Hospital

Tampa General Hospital

Saint Joseph's Hospital/Children's Hospital-Tampa

Saint Mary's Hospital

Saint Luke's Mountain States Tumor Institute

University of Illinois

Saint Jude Midwest Affiliate

Southern Illinois University School of Medicine

University of Kentucky/Markey Cancer Center

Norton Children's Hospital

Tulane University Health Sciences Center

Ochsner Medical Center Jefferson

Sinai Hospital of Baltimore

Massachusetts General Hospital Cancer Center

Dana-Farber Cancer Institute

Wayne State University/Karmanos Cancer Institute

Bronson Methodist Hospital

Kalamazoo Center for Medical Studies

Columbia Regional

University of Missouri - Ellis Fischel

Children's Mercy Hospitals and Clinics

Children's Hospital and Medical Center of Omaha

University of Nebraska Medical Center

University Medical Center of Southern Nevada

Nevada Cancer Research Foundation CCOP

Sunrise Hospital and Medical Center

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Summerlin Hospital Medical Center

Hackensack University Medical Center

Morristown Medical Center

Overlook Hospital

Albany Medical Center

Montefiore Medical Center - Moses Campus

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

Carolinas Medical Center/Levine Cancer Institute

Wake Forest University Health Sciences

Children's Hospital Medical Center of Akron

Rainbow Babies and Childrens Hospital

Cleveland Clinic Foundation

Dayton Children's Hospital

University of Oklahoma Health Sciences Center

Children's Hospital of Pittsburgh of UPMC

BI-LO Charities Children's Cancer Center

Greenville Cancer Treatment Center

East Tennessee Childrens Hospital

Texas Tech University Health Sciences Center-Amarillo

Driscoll Children's Hospital

Covenant Children's Hospital

UMC Cancer Center / UMC Health System

Methodist Children's Hospital of South Texas

University of Texas Health Science Center at San Antonio

Madigan Army Medical Center

British Columbia Children's Hospital

Centre Hospitalier Universitaire Sainte-Justine

Saskatoon Cancer Centre

Collecting and Storing Tissue From Young Patients With Cancer

Establishing Continuous Cell Lines and Xenografts From Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies

Children's Oncology Group

National Cancer Institute (NCI)

retinoblastoma

tyrosine

retinoblastoma/tyrosine

A Phase II Clinical Trial of Cediranib and Olaparib Maintenance in Advanced Recurrent Cervical Cancer

Collecting and Storing Tissue From Young Patients With Cancer

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