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

Primary Peritoneal Cavity Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023712
• Other study ID #: NCI-2012-02404
• Secondary ID: NCI-2012-02404CD
• Status: Completed
• Phase: Phase 2
• Start date: November 5, 2001
• Est. completion date: January 2010

Study information

• Verified date: July 2019
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Primary Peritoneal Cavity Cancer
• Recurrent Ovarian Epithelial Cancer

Intervention

Drug:
• bortezomib
Given IV

Other:
• laboratory biomarker analysis
Correlative studies
• pharmacological study
Correlative studies

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From study entry, up to 5 years
Primary	Frequency and Severity of Observed Adverse Events		Up to 5 years
Primary	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.	From study entry until disease progression/intolerable toxicity/study withdrawal
Secondary	Overall Survival		From study entry, up to 5 years following disease progression
Secondary	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.	From study entry up to 5 years