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Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bortezomib
carboplatin
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer Recurrent or progressive disease Received at least 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease May include high-dose therapy, consolidation, or extended therapy after surgical or non-surgical assessment No brain metastases or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8.0 g/dL Hepatic: AST and ALT no greater than 2.5 times upper limit of normal Bilirubin no greater than 1.8 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF greater than 50% by radionuclide ventriculogram or two-dimensional echocardiogram No peripheral vascular disease requiring surgical management No prior myocardial infarction No congestive heart failure No orthostatic hypotension No acute ischemia or significant conduction abnormality (bifascicular block, defined as left anterior hemiblock with right bundle branch block, second or third degree AV blocks) as evidenced by electrocardiogram No prior cerebrovascular event Other: No peripheral neuropathy grade 2 or greater No other serious medical or psychiatric illness Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 2 prior regimens for recurrent disease, including 1 non-platinum containing regimen At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered Endocrine therapy: At least 1 week since prior hormonal therapy directed at primary tumor Concurrent hormone replacement therapy allowed Radiotherapy: Not specified Surgery: See Disease Characteristics At least 2 weeks since prior major surgery

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 4, 2002
Last Updated
April 23, 2011
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00028912
Brief Title
Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Official Title
Phase I Trial of Bortezomib (NSC 681239, IND#58443) and Carboplatin in Recurrent or Progressive Epithelial Ovarian Cancer or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may help carboplatin kill more tumor cells by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with carboplatin in treating patients who have recurrent or progressive ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of bortezomib in combination with carboplatin in patients with recurrent or progressive ovarian epithelial, primary peritoneal, or fallopian tube cancer. Determine the toxicity of this regimen in these patients. Determine the pharmacodynamics of this regimen in these patients by measurement of 20S proteasome inhibition in whole blood. Correlate toxicity with 20S proteasome inhibition in a whole blood assay in patients treated with this regimen. OUTLINE: This is a dose-escalation study of bortezomib. Patients receive carboplatin IV over 30 minutes on days 1 and 8 followed by 1 week of rest during the first course of treatment. Beginning with the second course, patients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 8 additional patients are accrued and treated at that dose. PROJECTED ACCRUAL: A total of 3-32 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bortezomib
Intervention Type
Drug
Intervention Name(s)
carboplatin

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer Recurrent or progressive disease Received at least 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease May include high-dose therapy, consolidation, or extended therapy after surgical or non-surgical assessment No brain metastases or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8.0 g/dL Hepatic: AST and ALT no greater than 2.5 times upper limit of normal Bilirubin no greater than 1.8 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF greater than 50% by radionuclide ventriculogram or two-dimensional echocardiogram No peripheral vascular disease requiring surgical management No prior myocardial infarction No congestive heart failure No orthostatic hypotension No acute ischemia or significant conduction abnormality (bifascicular block, defined as left anterior hemiblock with right bundle branch block, second or third degree AV blocks) as evidenced by electrocardiogram No prior cerebrovascular event Other: No peripheral neuropathy grade 2 or greater No other serious medical or psychiatric illness Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 2 prior regimens for recurrent disease, including 1 non-platinum containing regimen At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered Endocrine therapy: At least 1 week since prior hormonal therapy directed at primary tumor Concurrent hormone replacement therapy allowed Radiotherapy: Not specified Surgery: See Disease Characteristics At least 2 weeks since prior major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Aghajanian, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16135465
Citation
Aghajanian C, Dizon DS, Sabbatini P, Raizer JJ, Dupont J, Spriggs DR. Phase I trial of bortezomib and carboplatin in recurrent ovarian or primary peritoneal cancer. J Clin Oncol. 2005 Sep 1;23(25):5943-9. doi: 10.1200/JCO.2005.16.006.
Results Reference
result
Citation
Aghajanian C, Dizon D, Yan XJ, et al.: Phase I trial of PS-341 and carboplatin in recurrent ovarian cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1815, 2003.
Results Reference
result

Learn more about this trial

Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

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