Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma
Recruitment status was Active, not recruiting
Tracking Information | |||||
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First Received Date ICMJE | May 6, 2003 | ||||
Last Updated Date | April 4, 2009 | ||||
Start Date ICMJE | March 2003 | ||||
Estimated Primary Completion Date | November 2003 (final data collection date for primary outcome measure) | ||||
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Change History | Complete list of historical versions of study NCT00060112 on ClinicalTrials.gov Archive Site | ||||
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma | ||||
Official Title ICMJE | A Phase I Study of Oblimersen (Genasense, G3139) in Combination With Gemcitabine in Advanced Malignancies | ||||
Brief Summary | RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of gemcitabine by making cancer cells more sensitive to the drug. PURPOSE: This phase I trial is studying the side effects and best dose of oblimersen and gemcitabine in treating patients with metastatic or unresectable solid tumors or lymphoma. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients receive oblimersen IV continuously on days 1-5 and gemcitabine IV over 2-3 hours on day 5. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen and gemcitabine 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. Up to 10 additional patients receive treatment at the MTD. PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study within 6-8 months. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Primary Purpose: Treatment | ||||
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Intervention ICMJE |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | |||||
Completion Date | |||||
Estimated Primary Completion Date | November 2003 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00060112 | ||||
Other Study ID Numbers ICMJE | CDR0000299507, SUMC-78808, NCI-5908 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Stanford University | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | August 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |