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Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Primary Purpose

Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
laboratory biomarker analysis
pharmacological study
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 Cavity Cancer

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed persistent or recurrent ovarian epithelial or primary peritoneal carcinoma Measurable disease At least 20 mm by conventional techniques (e.g., palpation, x-ray, plain CT scan, or MRI) OR at least 10 mm by spiral CT scan Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen for primary disease (e.g., carboplatin, cisplatin, or other organoplatinum compound) A second regimen containing paclitaxel allowed provided patient received no prior paclitaxel therapy Platinum-sensitive disease Treatment-free interval without progressive disease for more than 6 months but less than 12 months after therapy with platinum-based regimen At least 1 target lesion outside previously irradiated field Ineligible for higher priority GOG protocol Performance status - GOG 0-2 (if received 1 prior therapy regimen) Performance status - GOG 0-1 (if received 2 prior therapy regimens) Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN No evidence of acute ischemia or significant conduction abnormality (e.g., left anterior hemiblock in the presence of right bundle branch block or second or third degree atrioventricular block) on electrocardiogram No myocardial infarction within the past 6 months No cerebrovascular event or transient ischemic attack within the past 6 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other invasive malignancy within the past 5 years except non-melanoma skin cancer No sensory or motor neuropathy greater than grade 1 No more than 1 prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) for recurrent or persistent disease At least 4 weeks since prior biological or immunological agents and recovered No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimen At least 4 weeks since prior chemotherapy and recovered At least 1 week since prior anti-cancer hormonal therapy and recovered Concurrent hormone replacement therapy allowed At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to target lesions No prior radiotherapy to more than 25% of marrow-bearing areas At least 4 weeks since prior surgery and recovered No prior bortezomib No prior anti-cancer therapy that would preclude study treatment No concurrent amifostine or other protective agents

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (bortezomib)

Arm Description

Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Tumor Response Duration
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Frequency and Severity of Observed Adverse Events
Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD.

Secondary Outcome Measures

Overall Survival
Progression-Free Survival
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

Full Information

First Posted
September 13, 2001
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
NCT00023712
Brief Title
Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Official Title
A Phase II Evaluation of Bortezomib (Velcade™, PS-341, NSC #681239, IND #58443) in the Treatment of Persistent or Recurrent Platinum-Sensitive Epithelial Ovarian or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 5, 2001 (Actual)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (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
Phase II trial to study the effectiveness of bortezomib in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the antitumor activity of bortezomib in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma. II. Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment (bortezomib)
Arm Type
Experimental
Arm Description
Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
bortezomib
Other Intervention Name(s)
LDP 341, MLN341, VELCADE
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Tumor Response Duration
Description
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time Frame
From study entry, up to 5 years
Title
Frequency and Severity of Observed Adverse Events
Time Frame
Up to 5 years
Title
Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Description
Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD.
Time Frame
From study entry until disease progression/intolerable toxicity/study withdrawal
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
From study entry, up to 5 years following disease progression
Title
Progression-Free Survival
Description
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time Frame
From study entry up to 5 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed persistent or recurrent ovarian epithelial or primary peritoneal carcinoma Measurable disease At least 20 mm by conventional techniques (e.g., palpation, x-ray, plain CT scan, or MRI) OR at least 10 mm by spiral CT scan Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen for primary disease (e.g., carboplatin, cisplatin, or other organoplatinum compound) A second regimen containing paclitaxel allowed provided patient received no prior paclitaxel therapy Platinum-sensitive disease Treatment-free interval without progressive disease for more than 6 months but less than 12 months after therapy with platinum-based regimen At least 1 target lesion outside previously irradiated field Ineligible for higher priority GOG protocol Performance status - GOG 0-2 (if received 1 prior therapy regimen) Performance status - GOG 0-1 (if received 2 prior therapy regimens) Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN No evidence of acute ischemia or significant conduction abnormality (e.g., left anterior hemiblock in the presence of right bundle branch block or second or third degree atrioventricular block) on electrocardiogram No myocardial infarction within the past 6 months No cerebrovascular event or transient ischemic attack within the past 6 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other invasive malignancy within the past 5 years except non-melanoma skin cancer No sensory or motor neuropathy greater than grade 1 No more than 1 prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) for recurrent or persistent disease At least 4 weeks since prior biological or immunological agents and recovered No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimen At least 4 weeks since prior chemotherapy and recovered At least 1 week since prior anti-cancer hormonal therapy and recovered Concurrent hormone replacement therapy allowed At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to target lesions No prior radiotherapy to more than 25% of marrow-bearing areas At least 4 weeks since prior surgery and recovered No prior bortezomib No prior anti-cancer therapy that would preclude study treatment No concurrent amifostine or other protective agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Aghajanian
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

Learn more about this trial

Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

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