Ovarian Cancer Clinical Trial
Official title:
A Phase II Trial of Oral Sorafenib (Bay43-9006) In Women With Epithelial Ovarian, Fallopian Tube Or Peritoneal Carcinoma In Second Or Greater Remission
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with
ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer in at least the
second remission.
Status | Terminated |
Enrollment | 6 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum - Any stage and grade at diagnosis - Must have received initial cytoreductive surgery and chemotherapy with = 1 platinum-based chemotherapy regimen - Persistent or recurrent disease after initial therapy - In complete clinical remission after chemotherapy for recurrent disease, meeting all of the following criteria: - CA125 = 35 units/L - Normal physical examination - No definite evidence of disease by CT scan of the abdomen and pelvis - Lymph nodes and/or soft tissue abnormalities = 1.0 cm are not considered definite evidence of disease - No known brain metastases PATIENT CHARACTERISTICS: Inclusion criteria: - Karnofsky performance status 70-100% - Life expectancy > 3 months - ANC = 1,500/mm³ - Platelet count = 100,000/mm³ - Hemoglobin = 9.0 g/dL - INR < 1.5 OR PT/PTT within normal limits - Creatinine = 1.5 times upper limit of normal (ULN) - Urinalysis negative for protein - If urinalysis shows 1+ protein by dipstick or protein = 30-100 mg/dL by semi-quantitative assay, a 24-hour urine collection is required - Eligible patients must have a total urinary protein = 500 mg AND measured creatinine clearance = 50 mL/min from a 24-hour urine collection - Bilirubin = 1.5 times ULN - AST and ALT = 2.5 times ULN - Alkaline phosphatase = 2.5 times ULN - Stable blood pressure (BP) measurement required on 3 separate days prior to the start of treatment - No peripheral neuropathy > grade 1 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception Exclusion criteria: - Other invasive malignancies within the past 5 years, except nonmelanoma skin cancer - Uncontrolled concurrent illness or medical condition including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Uncontrolled diabetes - Psychiatric illness or social situation that would preclude study compliance - Uncontrolled hypertension defined as a persistent BP > 150/100 mm Hg (or a persistent BP > 180/90 mm Hg if the patient has a history of isolated systolic hypertension) despite = 2 attempts at antihypertensive medication dosage adjustment = 2 weeks apart - Thrombolic or embolic events such as cerebrovascular accident, including transient ischemic attack, within the past 6 months - Pulmonary hemorrhage or bleeding event = grade 2 within 4 weeks of the first dose of study drug - Other hemorrhage or bleeding event = grade 3 within 4 weeks of the first dose of study drug - Serious nonhealing wound, ulcer, or bone fracture - Evidence or history of bleeding diathesis or coagulopathy - Inability to take oral medications or gastrointestinal condition that compromises absorption - History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib tosylate PRIOR CONCURRENT THERAPY: Inclusion criteria: - See Disease Characteristics - No prior sorafenib tosylate or other inhibitors of MAPK signaling intermediates or angiogenesis inhibitors - No prior cancer treatment that would contraindicate protocol therapy - More than 4 weeks since prior radiotherapy - More than 3 weeks since prior chemotherapy, biological therapy, or immunotherapy - More than 1 week since prior hormonal therapy for cancer treatment Exclusion criteria: - Major surgery (i.e., laparotomy) within the past 4 weeks or minor surgery within the past 2 weeks - Placement of a vascular access device is not considered minor surgery - Concurrent combination antiretroviral therapy for HIV-positive patients - Concurrent St. John wort, rifampin, or enzyme-inducing anticonvulsants (e.g., carbamazepine, phenytoin, or phenobarbital) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan - Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Bayer, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival (PFS) Rate at 12 Months | All 5 patients experienced a rash. As a result, all 5 were either advised to withdraw from the protocol, or withdrew themselves from the protocol. The outcome was not met. | 1 year | No |
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