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Status:

COMPLETED

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

Lead Sponsor:

SCRI Development Innovations, LLC

Collaborating Sponsors:

Bayer

Conditions:

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

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 cytoreductiv...

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 paclitaxe...

Eligibility Criteria

Inclusion

  • Histologically confirmed, stage III or IV epithelial ovarian carcinoma
  • No previous treatment with chemotherapy or radiation therapy
  • All patients must have undergone cytoreductive surgery, with the
  • following results:
  • No residual tumor nodule \> 3cm
  • No residual tumor involvement of the bowel (ie. invasion into bowel
  • wall)
  • No residual intestinal obstruction
  • Measurable or evaluable disease. Patients with elevated CA-125 levels
  • and/or evaluable disease per RECIST criteria are eligible.
  • ECOG performance status 0 or 1.
  • ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL.
  • 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)
  • Serum creatinine \_ 1.5 x ULN
  • 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.
  • Women of childbearing potential must have a negative serum pregnancy
  • test performed within 7 days prior to start of treatment.
  • Patients must be able to understand the nature of this study and give
  • written informed consent.

Exclusion

  • Age \< 18 years
  • 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
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Patients with CNS metastases. Patients with neurological symptoms
  • must undergo a CT scan/MRI of the brain to exclude brain metastasis.
  • Uncontrolled hypertension defined as systolic blood pressure \> 150mmHg or diastolic pressure \> 90mmHg, despite optimal medical management
  • Known HIV, chronic hepatitis B or chronic hepatitis C infections
  • 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.
  • Active clinically serious infection (\> grade 2)
  • Thrombotic or embolic events such as cerebral vascular accident
  • including transient ischemic attacks within the last 6 months.
  • Pulmonary hemorrhage/bleeding event ≥ grade 2 within 4 weeks of
  • starting treatment.
  • Any other hemorrhage/bleeding event ≥ grade 3 within 4 weeks of
  • starting treatment
  • Serious non-healing wound, ulcer, or bone fracture
  • Evidence of history of bleeding diathesis or coagulopathy
  • Major surgery, open biopsy, or significant traumatic injury within 4 weeks
  • of starting treatment.
  • Any condition that impairs the ability to swallow whole pills
  • Patients with any type of malabsorption
  • Known or suspected allergy to any of the agents used in this treatment
  • Use of St. John's Wort or rifampin

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2014

Estimated Enrollment :

85 Patients enrolled

Trial Details

Trial ID

NCT00390611

Start Date

October 1 2006

End Date

April 1 2014

Last Update

December 22 2014

Active Locations (17)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (17 locations)

1

Northeast Arkansas Clinic

Jonesboro, Arkansas, United States, 72401

2

Holy Cross Hospital

Fort Lauderdale, Florida, United States, 33308

3

Florida Cancer Specialists

Fort Myers, Florida, United States, 33901

4

Gulfcoast Oncology Associates

St. Petersburg, Florida, United States, 33705