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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00023712
First received: September 13, 2001
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Drug: bortezomib
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of PS-341 (NSC# 681239) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor Response Duration [ Time Frame: From study entry, up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and Severity of Observed Adverse Events [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [ Time Frame: From study entry until disease progression/intolerable toxicity/study withdrawal ] [ Designated as safety issue: No ]
    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 [ Time Frame: From study entry, up to 5 years following disease progression ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: From study entry up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2004
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023712

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Carol Aghajanian Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00023712     History of Changes
Other Study ID Numbers: NCI-2012-02404, GOG-0146N, U10CA027469, CDR0000068853
Study First Received: September 13, 2001
Results First Received: September 17, 2013
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014