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

NCT00522301 | Terminated Phase 2 Results

• 4 other identifiers: 07-080P30CA008748MSKCC-07080BAYER-MSKCC-07-080
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer; stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Oral Sorafenib (BAY43-9006)

EXPERIMENTAL

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.

Drug: sorafenib tosylate; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

sorafenib tosylate DRUG

Oral Sorafenib (BAY43-9006)

immunoenzyme technique OTHER

Oral Sorafenib (BAY43-9006)

immunohistochemistry staining method OTHER

Oral Sorafenib (BAY43-9006)

laboratory biomarker analysis OTHER

Oral Sorafenib (BAY43-9006)

pharmacological study OTHER

Oral Sorafenib (BAY43-9006)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Bayer: collaborator

Study Sites (1)

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Sorafenib; Immunoenzyme Techniques; Immunohistochemistry

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Immunoassay; Immunologic Techniques; Investigative Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques

Limitations and Caveats

Early termination as it would not meet it's primary endpoint of improved survival. None of the patients completed the study.

Results Point of Contact

• Title: Dr. William Tew
• Organization: Memorial Sloan Kettering Cancer Center

teww@mskcc.org

646-888-4220

Study Officials

• William P. Tew, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Paul Sabbatini, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2007
• First Posted: August 29, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 29, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-02

Locations

US (1)