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| Sponsor: | Sarah Cannon Research Institute |
|---|---|
| Collaborator: |
Bayer |
| Information provided by (Responsible Party): | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00390611 |
Purpose
This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone vs. standard chemotherapy + sorafenib in patients with stage III/IV ovarian cancer following cytoreductive surgery. Patients with residual large volume disease and/or bowel involvement will be excluded, to minimize the risk of bowel perforation.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: Sorafenib Drug: Paclitaxel Drug: Carboplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
|
Drug: Sorafenib
Sorafenib
Drug: Paclitaxel
Paclitaxel
Drug: Carboplatin
Carboplatin
|
|
Active Comparator: 2
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
|
Drug: Paclitaxel
Paclitaxel
Drug: Carboplatin
Carboplatin
|
All patients must be at least 4 weeks from cytoreductive surgery before starting treatment. Patients will be randomized to receive treatment with either paclitaxel/carboplatin + sorafenib or paclitaxel/carboplatin. Paclitaxel/carboplatin will be repeated every 21 days for a maximum of 6 cycles. Patients with objective response/stable disease after completing 6 courses of chemotherapy will continue sorafenib until disease progression or for a total of 12 months.
- Regimen A: Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
- Regimen B: Paclitaxel 175mg/m2, 1-3 hour IV infusion, Day 1 Carboplatin AUC 6.0, 20 minute IV infusion, Day 1
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients must have undergone cytoreductive surgery, with the following results:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Clearview Cancer Institute | |
| Huntsville, Alabama, United States, 35805 | |
| United States, Arkansas | |
| Northeast Arkansas Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, Florida | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| Gulfcoast Oncology Associates | |
| St. Petersburg, Florida, United States, 33705 | |
| United States, Georgia | |
| Medical College of Georgia Cancer Specialists | |
| Augusta, Georgia, United States, 30912 | |
| United States, Indiana | |
| Providence Medical Group | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Michigan | |
| Grand Rapids Clinical Oncology Program | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Ohio | |
| Oncology Hematology Care | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, South Carolina | |
| South Carolina Oncology Associates, PA | |
| Columbia, South Carolina, United States, 29210 | |
| United States, Tennessee | |
| Family Cancer Center | |
| Collierville, Tennessee, United States, 38017 | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
| Principal Investigator: | John D. Hainsworth, MD | Sarah Cannon Research Institute |
More Information
| Responsible Party: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00390611 History of Changes |
| Other Study ID Numbers: | SCRI GYN 19, SR05-918 |
| Study First Received: | October 19, 2006 |
| Last Updated: | November 18, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Ovarian Cancer |
|
Ovarian 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 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 Enzyme Inhibitors |