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

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

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).

Study Overview

• Status: Completed
• Conditions: Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
• Intervention / Treatment: Drug: Carboplatin; Drug: Paclitaxel; Drug: Sorafenib Tosylate

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center at Tampa General Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Mentor, Ohio, United States, 44060
      • Lake University Ireland Cancer Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (closed to accrual 10/10/2008); 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	Drug: Sorafenib Tosylate; Given orally; Other Names: BAY 54-9085; Nexavar; BAY 43-9006 Tosylate; sorafenib
Experimental: 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.	Drug: Carboplatin; Given IV; Other Names: Blastocarb; Carboplat; Carboplatin Hexal; Carboplatino; Carbosin; Carbosol; Carbotec; CBDCA; Displata; Ercar; JM-8; Nealorin; Novoplatinum; Paraplatin; Paraplatin AQ; Paraplatine; Platinwas; Ribocarbo; Paraplat; Drug: Paclitaxel; Given IV; Other Names: Taxol; Anzatax; Asotax; Bristaxol; Praxel; Taxol Konzentrat; Drug: Sorafenib Tosylate; Given orally; Other Names: BAY 54-9085; Nexavar; BAY 43-9006 Tosylate; sorafenib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	after 6 weeks (2 cycles)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 85 months of follow-up
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.	up to 85 months of follow-up

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Steven Waggoner, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): April 21, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: November 9, 2004
• First Submitted That Met QC Criteria: November 8, 2004
• First Posted (Estimate): November 9, 2004

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Disease Attributes; Adnexal Diseases; Fallopian Tube Diseases; Carcinoma; Recurrence; Fallopian Tube Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Protein Kinase Inhibitors; Carboplatin; Paclitaxel; Sorafenib; Albumin-Bound Paclitaxel
• Other Study ID Numbers: NCI-2009-00067 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U01CA062502 (U.S. NIH Grant/Contract); P30CA043703 (U.S. NIH Grant/Contract); N01CM62208 (U.S. NIH Grant/Contract); CASE 2804 (Other Identifier: Case Comprehensive Cancer Center); CDR0000390331; 6557 (Other Identifier: CTEP)