Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second Remission

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Bayer; National Cancer Institute (NCI)
• Treatments: Niacinamide; Sorafenib

Criteria

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)