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

NCT ID: NCT00522301

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-03-31

Brief 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.

Detailed Description

OBJECTIVES:

Primary

• To determine the 12-month progression-free survival (PFS) rate of women with ovarian epithelial, fallopian tube, or peritoneal cancer in second or greater remission treated with oral sorafenib tosylate.

Secondary

• To determine the safety and tolerability of prolonged treatment with oral sorafenib tosylate in women with a history of recurrent ovarian cancer.
• To correlate serum markers of angiogenesis (i.e., VEGF and bFGF) and tumor markers pAKT, HIF-1 α , and VEGF with 12-month PFS.

OUTLINE: Patients receive oral sorafenib twice a day on days 1-28. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection at baseline, every 12 weeks during study, and after completion of study therapy for pharmacokinetic studies. Samples are analyzed for soluble markers of angiogenesis (i.e., VEGF and bFGF) via ELISA and HIF-1 α, VEGF, and pAKT via IHC staining.

After completion of study treatment, patients are followed at 4 weeks.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Sorafenib (BAY43-9006)

Sorafenib is supplied as 200-mg tablets. Sorafenib will be administered as 400 mg orally daily x 28 days (continuous). One cycle = 28 days. There is no planned treatment interruption between cycles. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating). In the absence of intolerable toxicity, a patient may continue to receive treatment with sorafenib until disease progression, or until 24 months have elapsed.

Group Type: EXPERIMENTAL

sorafenib tosylate

Intervention Type: DRUG

immunoenzyme technique

Intervention Type: OTHER

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

Interventions

sorafenib tosylate

Intervention Type: DRUG

immunoenzyme technique

Intervention Type: OTHER

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• 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:

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William P. Tew, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Paul Sabbatini, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan - Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

P30CA008748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-07080

Identifier Type: -

Identifier Source: secondary_id

BAYER-MSKCC-07-080

Identifier Type: -

Identifier Source: secondary_id

07-080

Identifier Type: -

Identifier Source: org_study_id