| GOG-0240 | A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC #704865, IND #7921) Versus the Non-Platinum Doublet, Topotecan Plus Paclitaxel, With and Without NCI-Supplied Bevacizumab, in Stage IVB, Recurrent or (1702)-
Eligibility: click to view information
DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the cervix, including any of the following subtypes:
Squamous cell carcinoma
Adenosquamous cell carcinoma
Adenocarcinoma
Primary stage IVB, recurrent, or persistent disease not amenable to curative treatment with surgery and/or radiotherapy
Measurable disease, defined as = 1 unidimensionally measurable lesion = 20 mm by conventional techniques or = 10 mm by spiral CT scan
Biopsy confirmation required if target lesion(s) measures < 30 mm or if the treating physician determines it is clinically indicated
Has = 1 "target lesion" that can be used to assess response
Tumors within a previously irradiated field are designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence = 90 days following completion of radiotherapy
No history or evidence of CNS disease, including primary brain tumor, brain metastases, or craniospinal metastases
PATIENT CHARACTERISTICS:
GOG performance status 0-1
ANC = 1,500/mm³
Platelet count = 100,000/mm³
Bilirubin = 1.5 times normal
SGOT = 2.5 times normal
Alkaline phosphatase = 2.5 times normal
PT/INR = 1.5 (or in-range INR, if patient is on a stable dose of therapeutic warfarin for management of venous thrombosis, including pulmonary thromboembolus)
PTT < 1.2 times upper limit of normal
Serum creatinine normal OR creatinine clearance = 60 mL/min
Urine protein:creatinine ratio 1.0 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for = 6 months after completion of study treatment
No active infection requiring antibiotics
No significant traumatic injury within the past 28 days
No serious non-healing wound, ulcer, or bone fracture
Patients with granulating incisions healing by secondary intention are eligible provided there is no evidence of fascial dehiscence or infection AND the wound is examined weekly
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 3-6 months
Patients must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation
No clinical symptoms or signs of gastrointestinal obstruction requiring parenteral hydration and/or nutrition
No active bleeding or pathologic condition that carries a high risk of bleeding (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels)
No seizures not controlled with standard medical therapy
No cerebrovascular accident (i.e., stroke), transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
No clinically significant cardiovascular disease, including any of the following:
Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
Myocardial infarction or unstable angina within the past 6 months
NYHA class II-IV congestive heart failure
Serious cardiac arrhythmia requiring medication
Atrial fibrillation allowed provided it is asymptomatic and ventricular rate is controlled
Significant peripheral vascular disease (i.e., = grade 2 peripheral vascular disease, as defined by NCI CTCAE v3.0 criteria)
No bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage
No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
No other invasive malignancy within the past 5 years, except nonmelanoma skin cancer
No other medical history or condition that, in the opinion of the investigator, would preclude study participation
No peripheral neuropathy = grade 2
PRIOR CONCURRENT THERAPY:
Recovered from all prior therapy
No prior anti-cancer therapy that would preclude study therapy
No prior anti-VEGF drugs, including bevacizumab
No prior chemotherapy unless given concurrently with radiotherapy
Prior paclitaxel and/or topotecan with radiotherapy not allowed
At least 6 weeks since
- Consent Forms: 0240 NCI Consent
|