Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer

NCT ID: NCT00390611

Last Updated: 2014-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2014-04-30

Brief Summary

This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone vs. standard chemotherapy plus 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.

Detailed Description

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

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel/Carboplatin/Sorafenib

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

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Paclitaxel

Carboplatin

Intervention Type: DRUG

Carboplatin

Paclitaxel/carboplatin

Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV

Group Type: ACTIVE_COMPARATOR

Paclitaxel

Intervention Type: DRUG

Paclitaxel

Carboplatin

Intervention Type: DRUG

Carboplatin

Interventions

Sorafenib

Intervention Type: DRUG

Paclitaxel

Paclitaxel

Intervention Type: DRUG

Carboplatin

Carboplatin

Intervention Type: DRUG

Other Intervention Names

BAY 43-9006

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed, stage III or IV epithelial ovarian carcinoma

2. No previous treatment with chemotherapy or radiation therapy

3. All patients must have undergone cytoreductive surgery, with the

following results:

1. No residual tumor nodule > 3cm

2. No residual tumor involvement of the bowel (ie. invasion into bowel

wall)

3. No residual intestinal obstruction

4. Measurable or evaluable disease. Patients with elevated CA-125 levels

and/or evaluable disease per RECIST criteria are eligible.

5. ECOG performance status 0 or 1.

6. ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL.

7. Total bilirubin ≤ 1.5 x upper limits of normal (ULN), ALT and AST ≤ 2.5 x

ULN (≤ 5 x ULN for patients with liver metastases)

8. Serum creatinine _ 1.5 x ULN

9. INR < 1.5 or a PT/PTT within normal limits. Patients receiving anticoagulation

treatment with an agent such as warfarin or heparin may be

allowed to participate. For patients on warfarin, the INR may be > 1.5,

and should be measured prior to initiation of sorafenib and monitored at

least weekly until INR is stable in the desired therapeutic range.

10. Women of childbearing potential must have a negative serum pregnancy

test performed within 7 days prior to start of treatment.

11. Patients must be able to understand the nature of this study and give

written informed consent.

Exclusion Criteria

1. Age < 18 years

2. Active cardiac disease, including: A) congestive heart failure > class II

NYHA , B) unstable angina or onset of angina within last 3 months, C) myocardial infarction within 6 months

3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

4. Patients with CNS metastases. Patients with neurological symptoms

must undergo a CT scan/MRI of the brain to exclude brain metastasis.

5. Uncontrolled hypertension defined as systolic blood pressure > 150mmHg or diastolic pressure > 90mmHg, despite optimal medical management

6. Known HIV, chronic hepatitis B or chronic hepatitis C infections

7. Women who are pregnant or lactating. Women of childbearing potential

must agree to use adequate contraception from time of study entry until

at least 3 months after the last administration of study drug.

8. Active clinically serious infection (> grade 2)

9. Thrombotic or embolic events such as cerebral vascular accident

including transient ischemic attacks within the last 6 months.

10. Pulmonary hemorrhage/bleeding event ≥ grade 2 within 4 weeks of

starting treatment.

11. Any other hemorrhage/bleeding event ≥ grade 3 within 4 weeks of

starting treatment

12. Serious non-healing wound, ulcer, or bone fracture

13. Evidence of history of bleeding diathesis or coagulopathy

14. Major surgery, open biopsy, or significant traumatic injury within 4 weeks

of starting treatment.

15. Any condition that impairs the ability to swallow whole pills

16. Patients with any type of malabsorption

17. Known or suspected allergy to any of the agents used in this treatment

18. Use of St. John's Wort or rifampin

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

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

Northeast Arkansas Clinic

Jonesboro, Arkansas, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Gulfcoast Oncology Associates

St. Petersburg, Florida, United States

Medical College of Georgia Cancer Specialists

Augusta, Georgia, United States

Providence Medical Group

Terre Haute, Indiana, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

National Capital Clinical Research Consortium

Bethesda, Maryland, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

South Carolina Oncology Associates, PA

Columbia, South Carolina, United States

Tennessee Valley Clinical Research

Chattanooga, Tennessee, United States

Family Cancer Center

Collierville, Tennessee, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Peninsula Cancer Center

Newport News, Virginia, United States

Countries

United States

References

Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Reference Type: DERIVED

PMID: 37185961 (View on PubMed)

Other Identifiers

SR05-918

Identifier Type: -

Identifier Source: secondary_id

SCRI GYN 19

Identifier Type: -

Identifier Source: org_study_id