Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer
NCT ID: NCT00323583
Last Updated: 2007-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2006-05-31
Brief Summary
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PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel, oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine.
Detailed Description
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* The primary objective is to determine the effectiveness the chemotherapy combination in improving the experience of those with advanced pancreatic cancer in
* Pain control and other aspects of quality of life
* Reduction of the tumor size or stabilization of tumor growth
* Progression free survival
* Overall survival
* The secondary objective is to determine the safety of this chemotherapy combination by monitoring and the managing the potential side effects
DOSE REGIMEN OUTLINE: Paclitaxel 60mg/m2 IV weekly; Oxaliplatin 50mg/m2 IV weekly; Leucovorin 20 mg/m2 IV weekly, minimum of 40 mg; 5FU 425mg/m2 IV weekly; Weekly for 12 weeks; Calcium and magnesium 1gram each IV prior to and after Oxaliplatin therapy; Glutathione 1500mg/m2 prior to Oxaliplatin
DURATION OF STUDY PERIOD: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay greater than 3 weeks, 12 weeks initially, can than continue at discretion of investigator.
EXPECTED NUMBER OF PATIENTS: A total of 80 patients (40 second line of treatment and 40 third line or greater of treatment) will be enrolled for this study beginning in May 2006.
QUALITY OF LIFE: Quality of life will be assessed at baseline, each month of treatment and at the end of study therapy.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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paclitaxel
oxaliplatin
leucovorin
5-fluorouracil
glutathione
calcium and magnesium
Chemotherapy
Chemoprotection
Complementary and alternative therapy
Eligibility Criteria
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Inclusion Criteria
Prior Therapy:
* For advanced disease allowed as above;
* Oxaliplatin or 5-FU will be allowed but a subset analysis will be done for this group of patients;
* Tarceva and/or Erbitux allowed, but subset analysis will be done.
Allergies:
* No known allergy to one of the study drugs
PATIENT CHARACTERISTICS:
* No CNS metastases
* No peripheral neuropathy \> grade 2
* ECOG Performance Status \<=2
* Age ≤ 65
* No other serious concomitant illness
* Fully recovered from any prior therapy
Lower Age Limit:
* \>18
Upper Age Limit:
* ≤ 65
Laboratory:
* ANC \>1500
* Platelets \>75,000
* Creatinine \<=2.0
Other:
* For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
Exclusion Criteria
* Uncontrolled serious concomitant disease
* Radiotherapy within the 6 weeks before Cycle 1' Day 1
* Surgery within the 2 weeks before Cycle 1' Day 1
18 Years
65 Years
ALL
No
Sponsors
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Seattle Cancer Treatment and Wellness Center
OTHER
Principal Investigators
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Ben Chue, MD
Role: PRINCIPAL_INVESTIGATOR
Seattle Cancer Treatment and Wellness Center
Locations
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Seattle Cancer Treatment and Wellness Center
Seattle, Washington, United States
Countries
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Central Contacts
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Ben Chue, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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CTCA06-02
Identifier Type: -
Identifier Source: org_study_id