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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00096200 |
Purpose
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin Drug: paclitaxel Drug: sorafenib tosylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer |
| Enrollment: | 44 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
|
Drug: sorafenib tosylate
Given orally
Other Name: BAY 54-9085
|
|
Experimental: Arm II
Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Other Name: Taxol
Drug: sorafenib tosylate
Given orally
Other Name: BAY 54-9085
|
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to performance status and participating center.
PROJECTED ACCRUAL: A total of 21-52 patients (9-24 for arm I [closed to accrual as of 10/10/2008] and 12-28 for arm II) will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer
Must have received a prior platinum-based regimen
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
Adequate intestinal function
No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other agents used in the study
No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor®El
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation therapy
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| Lake University Ireland Cancer Center | |
| Mentor, Ohio, United States, 44060 | |
| Southwest General Health Center | |
| Middleburg Heights, Ohio, United States, 44130 | |
| UHHS Chagrin Highlands Ireland Cancer Center | |
| Orange Village, Ohio, United States, 44122 | |
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298-0034 | |
| United States, West Virginia | |
| West Virginia University | |
| Morgantown, West Virginia, United States, 26506 | |
| Principal Investigator: | Steven E. Waggoner, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Steven Waggoner, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00096200 History of Changes |
| Other Study ID Numbers: | CASE2804, U01CA062502, P30CA043703, CASE-CWRU-2804, NCI-6557, CASE-2804 |
| Study First Received: | November 9, 2004 |
| Last Updated: | July 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer |
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Sorafenib Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Protein Kinase Inhibitors |