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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00390611
First received: October 19, 2006
Last updated: April 9, 2014
Last verified: April 2014

October 19, 2006
April 9, 2014
October 2006
October 2014   (final data collection date for primary outcome measure)
progression free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
progression free survival
Complete list of historical versions of study NCT00390611 on ClinicalTrials.gov Archive Site
Not Provided
  • objective response
  • overall survival
  • toxicity
Not Provided
Not Provided
 
Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer
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

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: Sorafenib
    Other Name: BAY 43-9006
  • Drug: Paclitaxel
    Paclitaxel
  • Drug: Carboplatin
    Carboplatin
  • Active Comparator: 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
    Interventions:
    • Drug: Sorafenib
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Active Comparator: Paclitaxel/carboplatin
    Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
85
October 2015
October 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00390611
SCRI GYN 19, SR05-918
No
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
Bayer
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP