Safety and Efficacy Study of Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) for Patients With Metastatic Adenocarcinoma of the Pancreas
This study is currently recruiting participants.
Verified July 2012 by Eastern Regional Medical Center
Sponsor:
Eastern Regional Medical Center
Information provided by (Responsible Party):
Eastern Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01654861
First received: July 13, 2012
Last updated: July 30, 2012
Last verified: July 2012
Tracking Information | |||||
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First Received Date ICMJE | July 13, 2012 | ||||
Last Updated Date | July 30, 2012 | ||||
Start Date ICMJE | June 2012 | ||||
Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Weekly for up to 6 months. ] [ Designated as safety issue: Yes ] Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01654861 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Anti-Tumor Response [ Time Frame: Every 2 months for up to 6 months. ] [ Designated as safety issue: No ] CT and PET scans will be performed at baseline and then every two months. Target and Non-Target Lesions will be identified and recorded at baseline. When subsequent scans are performed, anti-tumor responses will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST). |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy Study of Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) for Patients With Metastatic Adenocarcinoma of the Pancreas | ||||
Official Title ICMJE | Evaluation of the Safety and Efficacy of Standard Dose Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) Treatment for Patients With Metastatic Adenocarcinoma of the Pancreas. | ||||
Brief Summary |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Adenocarcinoma of the Pancreas | ||||
Intervention ICMJE | Drug: Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)
Weeks 1,2,3: IV Gemcitabine 1000 mg/m² over 30 minutes followed by HDIVC 1.2 g/kg over 90 minutes followed by 0.3 g/kg over 120 minutes; Week 4: no treatment. |
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Study Arm (s) | Experimental: HDIVC
Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Intervention: Drug: Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C) |
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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 | Recruiting | ||||
Estimated Enrollment ICMJE | 10 | ||||
Estimated Completion Date | June 2013 | ||||
Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01654861 | ||||
Other Study ID Numbers ICMJE | ERMC 11-11 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Eastern Regional Medical Center | ||||
Study Sponsor ICMJE | Eastern Regional Medical Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE | |||||
Information Provided By | Eastern Regional Medical Center | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |