Carboplatin and Paclitaxel With or Without Cediranib Maleate in Treating Patients With Metastatic or Recurrent Cervical Cancer That Cannot Be Removed by Surgery

DISEASE CHARACTERISTICS:

• Histologically confirmed carcinoma of the cervix, including any of the following subtypes:
• Squamous cell carcinoma
• Adenocarcinoma
• Adenosquamous cell carcinoma
• Must meet one of the following criteria:
• Persistent or relapsed inoperable disease after radical radiotherapy within the irradiated pelvis
• Relapse after radical hysterectomy (after radical radiotherapy to pelvis, if appropriate)
• Extra pelvic metastases
• Primary stage IVB disease
• Not suitable for potentially curative surgical procedure
• Measurable disease in ≥ 1 marker site
• No CNS disease, including brain metastases, within the past 6 months

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy > 12 weeks
• Hemoglobin ≥ 10 g/dL
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Calculated creatinine clearance ≥ 35 mL/min
• No proteinuria > 1+ on dipstick (on 2 consecutive dipsticks not less than 1 week apart), unless urinary protein is < 1.5 g in a 24-hour period
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT or AST ≤ 2.5 times ULN (≤ 5 times ULN if hepatic metastases present)
• Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if hepatic metastases present)
• Prothrombin ratio (PTR)/INR ≤ 1.5 OR PTR/INR 2.0-3.0 for patients on stable dose of anticoagulant
• Partial thromboplastin time < 1.2 times control
• No history of a nervous or psychiatric disorder that would prevent informed consent and compliance
• No prior malignancy within the past 5 years, except for successfully treated basal cell skin cancer or in-situ breast cancer
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
• No uncontrolled infection, defined as infection that cannot be resolved readily with antibiotics prior to trial entry
• No history of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib maleate
• No history of pelvic fistula
• No history of inflammatory bowel disease
• No sub-acute or acute intestinal obstruction
• No significant traumatic injury within the past 4 weeks
• No non-healing wound, ulcer, or bone fracture
• No active bleeding
• No history or evidence of thrombotic or hemorrhagic disorders
• No uncontrolled seizures, cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
• No significant cardiovascular disease, including any of the following:
• Arterial thrombotic event within the past 12 months
• Angina within the past 6 months
• History of poorly controlled or uncontrolled hypertension or resting BP > 150/100 mm Hg in the presence or absence of a stable regimen of anti-hypertensive therapy within the past 6 months
• NYHA class II-IV congestive heart failure
• Peripheral vascular disease ≥ grade 3 or cardiac arrhythmia requiring medication
• Prolonged QTc (corrected) interval of > 470 ms on ECG or a family history of long QT syndrome
• Patients with rate-controlled atrial fibrillation are eligible
• Not requiring intravenous nutritional support
• No preexisting sensory or motor neuropathy ≥ grade 2
• No history or clinical suspicion of spinal cord compression
• No known hypersensitivity to carboplatin or paclitaxel
• No evidence of any other disease, metabolic dysfunction, physical examination finding, or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No unresolved toxicity ≥ CTC grade 2 from prior systemic anti-cancer therapy, except hematological toxicity or alopecia
• No prior chemotherapy, except cisplatin administered along with radiotherapy as primary treatment
• No major surgery within 28 days or anticipated while on study
• More than 2 weeks since prior and no concurrent potent inhibitors of CYP3A4 and 2C8, including any of the following:
• Amiodarone
• Clarithromycin
• Erythromycin
• Simvastatin
• Atorvastatin
• Lovastatin
• Montelukast sodium
• Verapamil
• Ketoconazole
• Miconazole
• Indinavir (and other antivirals)
• Diltiazem
• No concurrent grapefruit juice or St. John wort