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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00636883 |
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Date of registration:
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08/03/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer
GEMOX-T |
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Scientific title:
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Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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9 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00636883 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Abdul-Rahman M Jazieh, MD,MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Guard Hospital Affairs |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient's age between 18 and 75 years.
2. Presence of microscopic diagnosis of pancreatic cancer.
3. The disease is Locally advanced deemed by the surgeon to be unresectable, or
metastatic disease.
4. Karnofsky Performance status >50%.
5. Prior radiotherapy for local diseases is allowed provided disease progression had
been documented, and treatment completed at least 4 weeks before random assignment
6. Prior chemotherapy is not permitted, except for fluorouracil given concurrently as a
radiosensitizer.
7. Patients must have normal organ function evidenced by
- Cr <1.5 ULN
- ANC >1000
- platelets> 100,000
- total bilirubin <1.5ULN.
8. Pain should be controlled for at least two weeks without an increase in the narcotic
consumption.
9. Biliary obstruction should be controlled for at least two weeks evident by stable or
improving liver function tests especially total bilirubin.
10. Patient has signed a Patient Informed Consent Form.
11. For all females of childbearing potential, a negative pregnancy test must be obtained
within 72 hours before starting therapy.
Exclusion Criteria:
1. Contraindication to chemotherapy.
2. Evidence of uncontrolled CNS disease (patients with controlled CNS disease for 4
weeks using the same imaging method and for whom are off steroid will be eligible)
3. Uncontrolled Nausea and Vomiting
4. Diagnosis of other malignancy in the last 5 years excluding non-melanoma skin cancer
and in -situ cervical cancer.
5. Subjects unlikely to comply with protocol, e.g. uncooperative attitude, inability to
return for follow- up visits and unlikelihood of completing the study.
6. Any known history of hypersensitivity to the study drugs.
7. Pregnant or lactating women.
8. Participation in a clinical trial with any investigational drug used with curative
intent and within 30 days prior to study entry
9. Peripheral sensitive neuropathy with functional impairment prior to study entry.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pancreatic Cancer
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Intervention(s)
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Drug: Gemcitabine
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Primary Outcome(s)
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Response rate (partial and complete response, stable disease, and progressive disease)
[Time Frame: Tumor response will be assessed following the induction therapy and after cycle 4,8 and at the end of the treatment.]
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Secondary Outcome(s)
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Overall survival
[Time Frame: UNMEASURABLE]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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