CIRCCa(Cediranib In Recurrent Cervical Cancer)A Randomised Double Blind Phase II trial of carboplatin-paclitaxel plus cediranib versus carboplatin-paclitaxel plus placebo in metastatic/recurrent cervical cancer - CIRCCa - Cediranib in Recurrent Cervical Cancer

• Conditions: Metastatic/ Recurrent carinoma of cervix; MedDRA version: 13.1Level: PTClassification code 10041848Term: Squamous cell carcinoma of the cervixSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1Level: LLTClassification code 10008224Term: Cervical adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2009-011542-25-GB
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-15
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•Female and over 18 years of age.
•ECOG performance status 0, or 1.
• Written Informed Consent
•Histologically proven carcinoma of the cervix (squamous, adenocarcinoma or adenosquamous mixed ).
•Either:
1.Persistent or relapsed inoperable disease after radical radiotherapy within the irradiated pelvis or
2.Relapse after radical hysterectomy (after radical radiotherapy to pelvis if appropriate) or
3.Extra pelvic metastases or
4.Stage IVb disease at diagnosis
•Patient not suitable for potentially curative surgical procedure.
•Measurable disease in at least one marker site.
•Adequate haematological function, as follows:
Haemoglobin > 10g/dl
Neutrophils > 1.5 x 109/l
Platelets > 100 x 109/l
Calculated Creatinine Clearance > 35mls/min (measured
by EDTA)
•Adequate biochemical function, as follows:
Bilirubin < 1.5 x ULN
ALT or AST < 2.5 x ULN (or =5 x ULN if hepatic
metastases present)
Alkaline Phosphatase < 2.5 x ULN (or =5 x ULN if hepatic metastases)
•Adequate coagulation, as follows:
Prothrombin ratio (PTR) / INR = 1.5 or
PTR / INR between 2.0 and 3.0 for patients on stable doses of anticoagulants
Partial thromboplastin time <1.2 x control
•Life expectancy >12 weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•They have received prior chemotherapy, except cisplatin administered along with radiotherapy as primary treatment.
•Relapse is confined to the pelvis after radical surgery in circumstance where radiotherapy or chemoradiotherapy would be appropriate.
•Relapse is potentially treatable with exenterative surgery.
•History of nervous or psychiatric disorder that would prevent informed consent and compliance
•History of prior malignancy within the previous 5 years except for successfully treated basal cell skin cancer or in-situ breast cancer
•Pregnant or lactating women.
•Fertile woman of childbearing potential not willing to use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least six months afterwards
•Evidence of uncontrolled infection.
•History of pelvic fistulae.
•Sub-acute or acute intestinal obstruction.
•Major surgery within 28 days or anticipated while on study.
•Significant traumatic injury during 4 weeks preceding the potential first dose of cediranib.
•Non-healing wound, ulcer or bone fracture.
•Active bleeding.
•History or evidence of thrombotic or haemorrhagic disorders.
•History of inflammatory bowel disease.
•Proteinuria > 1+ on dipstick on two consecutive dipsticks taken no less than 1 week apart, unless urinary protein is <1.5g in a 24 hour period.
•Significant cardiovascular disease (arterial thrombotic event within 12 months, uncontrolled hypertension or angina within 6 months, NYHA grade 2 congestive cardiac failure, grade = 3 peripheral vascular disease or cardiac arrhythmia requiring medication). Patients with rate-controlled atrial fibrillation are eligible.
•Prolonged QTc (corrected) interval of >470ms on ECG or a family history of long QT syndrome.
•CNS disease (brain metastases, uncontrolled seizures or cerebrovascular accident/transient ischaemic attack /subarachnoid haemorrhage within 6 months).
•History or clinical suspicion of spinal cord compression.
•Pre-existing sensory or motor neuropathy = grade 2.
•Known hypersensitivity to carboplatin or paclitaxel
•Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
•Any unresolved toxicity = CTC Grade 2 from previous systemic anti-cancer therapy except haematological toxicity (see inclusion criteria Adequate haematological function”) and alopecia.
•A history of poorly controlled hypertension or resting BP>150/100 mmHG in the presence or absence of a stable regimen of anti-hypertensive therapy (measurements will be made after the patient has been resting supine for a minimum of 5 minutes. Two or more readings should be taken at 2 minutes intervals and averaged. If the first two diastolic readings differ by more than 5mmHG, then an additional reading should be obtained and averaged).
•Requiring intravenous nutritional support.
•History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified