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Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Primary Purpose

Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Paclitaxel
Sorafenib Tosylate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Fallopian Tube Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer Recurrent disease Must have received a prior platinum-based regimen Platinum-sensitive (treatment-free interval > 6 months) No more than 2 prior chemotherapy regimens Measurable disease At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan Not in a prior irradiation field No known brain metastases Performance status: ECOG 0-2 OR Karnofsky 80-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 Hemoglobin >= 9 g/dL No bleeding diathesis Hepatic: Bilirubin < 1.5 times upper limit of normal (ULN) AST or ALT =< 2 times ULN No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other agents used in the study Patients who have had a reaction to a taxane or a platinum and have not yet been rechallenged may undergo a desensitization regimen on study No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor El: Prior hypersensitivity reaction to paclitaxel allowed provided rechallenged successfully Renal: Creatinine < 2 mg/dL Cardiovascular: Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed if stable for the past 6 months No symptomatic congestive heart failure No uncontrolled hypertension No cardiac arrhythmia No unstable angina pectoris; No myocardial infarction within the past 6 months Negative pregnancy test Fertile patients must use effective contraception Adequate intestinal function No concurrent requirements for IV hydration or nutritional support No active or ongoing infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness No other invasive malignancy with the past 5 years except nonmelanoma skin cancer More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered More than 3 weeks since prior hormonal therapy More than 4 weeks since prior radiotherapy and recovered No prior sorafenib No prior anticancer therapy that contraindicates study therapy No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort) No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent therapeutic anticoagulation therapy Concurrent prophylactic low-dose warfarin allowed for maintenance of venous or arterial access devices No other concurrent anticancer therapies No other concurrent investigational agents Not pregnant or nursing

Sites / Locations

  • Moffitt Cancer Center at Tampa General Hospital
  • Moffitt Cancer Center
  • Case Western Reserve University
  • Lake University Ireland Cancer Center
  • Virginia Commonwealth University/Massey Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (closed to accrual 10/10/2008)

Arm II

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.

Secondary Outcome Measures

Evaluate the Progression-free Survival Rate
Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.
Overall Survival
Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.

Full Information

First Posted
November 9, 2004
Last Updated
January 13, 2022
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00096200
Brief Title
Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 21, 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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. 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).
Detailed Description
PRIMARY OBJECTIVES : I. Compare the progression-free and overall survival rate of patients with recurrent platinum-sensitive ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with sorafenib with or without carboplatin and paclitaxel. (Arm I [sorafenib only] closed to accrual 10/01/2008) II. Evaluate the response rate and time to disease progression in patients treated with these regimens. OUTLINE: This is a multicenter study. Patients are stratified according to performance status and participating center. ARM I (closed to accrual 10/01/2008): 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (closed to accrual 10/10/2008)
Arm Type
Experimental
Arm Description
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
Arm Title
Arm II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Sorafenib Tosylate
Other Intervention Name(s)
BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Description
Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.
Time Frame
after 6 weeks (2 cycles)
Secondary Outcome Measure Information:
Title
Evaluate the Progression-free Survival Rate
Description
Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.
Time Frame
up to 85 months of follow-up
Title
Overall Survival
Description
Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.
Time Frame
up to 85 months of follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer Recurrent disease Must have received a prior platinum-based regimen Platinum-sensitive (treatment-free interval > 6 months) No more than 2 prior chemotherapy regimens Measurable disease At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan Not in a prior irradiation field No known brain metastases Performance status: ECOG 0-2 OR Karnofsky 80-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 Hemoglobin >= 9 g/dL No bleeding diathesis Hepatic: Bilirubin < 1.5 times upper limit of normal (ULN) AST or ALT =< 2 times ULN No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other agents used in the study Patients who have had a reaction to a taxane or a platinum and have not yet been rechallenged may undergo a desensitization regimen on study No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor El: Prior hypersensitivity reaction to paclitaxel allowed provided rechallenged successfully Renal: Creatinine < 2 mg/dL Cardiovascular: Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed if stable for the past 6 months No symptomatic congestive heart failure No uncontrolled hypertension No cardiac arrhythmia No unstable angina pectoris; No myocardial infarction within the past 6 months Negative pregnancy test Fertile patients must use effective contraception Adequate intestinal function No concurrent requirements for IV hydration or nutritional support No active or ongoing infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness No other invasive malignancy with the past 5 years except nonmelanoma skin cancer More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered More than 3 weeks since prior hormonal therapy More than 4 weeks since prior radiotherapy and recovered No prior sorafenib No prior anticancer therapy that contraindicates study therapy No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort) No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent therapeutic anticoagulation therapy Concurrent prophylactic low-dose warfarin allowed for maintenance of venous or arterial access devices No other concurrent anticancer therapies No other concurrent investigational agents Not pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Waggoner
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center at Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Lake University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

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