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

NCT ID: NCT00023712

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-05
• Study Completion Date: 2010-01-31

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.

Conditions

Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (bortezomib)

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

Group Type: EXPERIMENTAL

bortezomib

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

bortezomib

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

LDP 341; MLN341; VELCADE; pharmacological studies

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Oncology Group

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol Aghajanian

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02404

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000068853

Identifier Type: -

Identifier Source: secondary_id

GOG-0146N

Identifier Type: -

Identifier Source: secondary_id

GOG #0146N

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0146N

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02404

Identifier Type: -

Identifier Source: org_study_id