Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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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 |
- Frequency and duration of objective response [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
- Frequency and severity of observed adverse events [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]
- Survival time [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
- Duration of progression-free interval [ Time Frame: Up to 6 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:
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 |
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
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 |
| Last Updated: | January 14, 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 May 16, 2013