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Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

Primary Purpose

Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
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 Primary Peritoneal Carcinoma

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed ovarian epithelial or primary peritoneal carcinoma Persistent or recurrent disease Measurable or evaluable disease Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan Evaluable disease is defined as at least 1 of the following: CA 125 ≥ 2 times upper limit of normal (ULN) Ascites and/or pleural effusion attributed to tumor Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definition for target lesions Must have received 1 prior platinum-based chemotherapeutic regimen for primary disease, including carboplatin, cisplatin, or another organoplatinum compound Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment Platinum-resistant according to 1 of the following criteria: Treatment-free interval of < 12 months after platinum therapy Disease progression during platinum-based therapy Persistent disease after a platinum-based regimen Ineligible for higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population) No brain metastases Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen) Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens) Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No known bleeding diathesis Bilirubin ≤ 1.5 times ULN SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No uncontrolled hypertension Able to take oral medication No bowel obstruction or persistent vomiting No requirement for parenteral feedings Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study participation No sensory or motor neuropathy > grade 1 No active or ongoing infection requiring antibiotics No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib No serious chronic skin conditions (i.e., psoriasis or dermatitis) that would preclude study participation No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No other invasive malignancy within the past 5 years except nonmelanoma skin cancer At least 3 weeks since prior immunologic agents for the malignancy More than 4 weeks since prior mouse antibodies (for patients with evaluable disease only) No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF]) No concurrent prophylactic thrombopoietic agents except in the case of recurrent grade 4 thrombocytopenia No other concurrent biological agents for the primary tumor See Disease Characteristics More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior non-cytotoxic chemotherapy for persistent or recurrent disease No concurrent chemotherapy for the primary tumor At least 1 week since prior hormonal therapy for the malignancy No concurrent hormonal therapy for the primary tumor Concurrent hormone replacement therapy allowed More than 4 weeks since prior radiotherapy and recovered No prior radiotherapy to > 25% of marrow-bearing areas No concurrent radiotherapy More than 4 weeks since prior surgery involving the peritoneum or pleura (for patients with evaluable disease only) Recovered from prior surgery At least 3 weeks since other prior therapy for the malignancy No more than 1 additional prior cytotoxic regimen for persistent or recurrent disease No prior sorafenib No prior anticancer treatment that would preclude study participation No concurrent therapeutic oral anticoagulation therapy (i.e., warfarin) Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for central venous access devices allowed provided INR is < 1.5 No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational or commercial agents or therapies for the malignancy

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (sorafenib tosylate)

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.

Outcomes

Primary Outcome Measures

Frequency and severity of adverse events as assessed by CTCAE v3.0
Progression-free survival
Will be evaluated using proportional hazards modeling and Fisher's exact test.

Secondary Outcome Measures

Duration of overall survival
Will be evaluated using proportional hazards modeling and Fisher's exact test.
Duration of progression-free survival
Will be evaluated using proportional hazards modeling and Fisher's exact test.
Frequency of clinical response (complete and partial response) defined by RECIST criteria
Prognostic variables (platinum sensitivity, performance status, and cellular histology [clear cell or mucinous type])

Full Information

First Posted
October 6, 2004
Last Updated
July 22, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00093626
Brief Title
Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer
Official Title
A Phase II Evaluation of BAY 43-9006 (Sorafenib, Nexavar®, NCI-Supplied Agent, NSC #724772) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the efficacy of sorafenib in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma. II. Determine 6-month progression-free survival of patients treated with this drug. III. Determine the toxicity of this drug, in terms of frequency and severity of adverse events encountered, in these patients. SECONDARY OBJECTIVES: I. Determine the clinical response rate (partial and complete response) in patients treated with this drug. II. Determine the duration of progression-free and overall survival of patients treated with this drug. III. Correlate prognostic variables (platinum sensitivity, performance status, and histology [clear cell and mucinous type]) with response in patients treated with this drug. OUTLINE: This is a multicenter study. 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 are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 6-13 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (sorafenib tosylate)
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.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
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
Frequency and severity of adverse events as assessed by CTCAE v3.0
Time Frame
Up to 5 years
Title
Progression-free survival
Description
Will be evaluated using proportional hazards modeling and Fisher's exact test.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Duration of overall survival
Description
Will be evaluated using proportional hazards modeling and Fisher's exact test.
Time Frame
Up to 5 years
Title
Duration of progression-free survival
Description
Will be evaluated using proportional hazards modeling and Fisher's exact test.
Time Frame
Up to 5 years
Title
Frequency of clinical response (complete and partial response) defined by RECIST criteria
Time Frame
Up to 5 years
Title
Prognostic variables (platinum sensitivity, performance status, and cellular histology [clear cell or mucinous type])
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed ovarian epithelial or primary peritoneal carcinoma Persistent or recurrent disease Measurable or evaluable disease Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan Evaluable disease is defined as at least 1 of the following: CA 125 ≥ 2 times upper limit of normal (ULN) Ascites and/or pleural effusion attributed to tumor Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definition for target lesions Must have received 1 prior platinum-based chemotherapeutic regimen for primary disease, including carboplatin, cisplatin, or another organoplatinum compound Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment Platinum-resistant according to 1 of the following criteria: Treatment-free interval of < 12 months after platinum therapy Disease progression during platinum-based therapy Persistent disease after a platinum-based regimen Ineligible for higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population) No brain metastases Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen) Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens) Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No known bleeding diathesis Bilirubin ≤ 1.5 times ULN SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No uncontrolled hypertension Able to take oral medication No bowel obstruction or persistent vomiting No requirement for parenteral feedings Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study participation No sensory or motor neuropathy > grade 1 No active or ongoing infection requiring antibiotics No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib No serious chronic skin conditions (i.e., psoriasis or dermatitis) that would preclude study participation No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No other invasive malignancy within the past 5 years except nonmelanoma skin cancer At least 3 weeks since prior immunologic agents for the malignancy More than 4 weeks since prior mouse antibodies (for patients with evaluable disease only) No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF]) No concurrent prophylactic thrombopoietic agents except in the case of recurrent grade 4 thrombocytopenia No other concurrent biological agents for the primary tumor See Disease Characteristics More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior non-cytotoxic chemotherapy for persistent or recurrent disease No concurrent chemotherapy for the primary tumor At least 1 week since prior hormonal therapy for the malignancy No concurrent hormonal therapy for the primary tumor Concurrent hormone replacement therapy allowed More than 4 weeks since prior radiotherapy and recovered No prior radiotherapy to > 25% of marrow-bearing areas No concurrent radiotherapy More than 4 weeks since prior surgery involving the peritoneum or pleura (for patients with evaluable disease only) Recovered from prior surgery At least 3 weeks since other prior therapy for the malignancy No more than 1 additional prior cytotoxic regimen for persistent or recurrent disease No prior sorafenib No prior anticancer treatment that would preclude study participation No concurrent therapeutic oral anticoagulation therapy (i.e., warfarin) Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for central venous access devices allowed provided INR is < 1.5 No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational or commercial agents or therapies for the malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Matei
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

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Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

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