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

Stopped early · Phase 2

Conditions studied: Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

In brief

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.

Key facts

Study ID

NCT00522301

Run by

Memorial Sloan Kettering Cancer Center

People needed

6

Starts

2007-07-01

Expected to finish

2008-03-01

Last updated by the study team

2016-02-29

Who can join

Age: 18 and older, up to 120. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:

Where it is running

• Memorial Sloan - Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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