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| Sponsored by: |
Seattle Cancer Treatment and Wellness Center |
|---|---|
| Information provided by: | Seattle Cancer Treatment and Wellness Center |
| ClinicalTrials.gov Identifier: | NCT00323583 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and 5-fluoruracil, work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated promising responses in all patients. It is not yet known how effective this drug and dosing combination is in treating advanced pancreatic cancer.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarincoma of Pancreas Stage III Pancreatic Cancer Stage IVA Pancreatic Cancer Stage IVB Pancreatic Cancer |
Drug: paclitaxel Drug: oxaliplatin Drug: leucovorin Drug: 5-fluorouracil Drug: glutathione Drug: calcium and magnesium Procedure: Chemotherapy Procedure: Chemoprotection Procedure: Complementary and alternative therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2006 |
OBJECTIVES:
The primary objective is to determine the effectiveness the chemotherapy combination in improving the experience of those with advanced pancreatic cancer in
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS
Patients with pathologically-proven pancreatic adenocarcinoma, who
Gender Eligible for Study:
Prior Therapy:
Allergies:
PATIENT CHARACTERISTICS:
Lower Age Limit:
Upper Age Limit:
Laboratory:
Other:
Exclusion Criteria:
Contacts and Locations| Contact: Ben Chue, MD | 206-292-2277 | |
| Contact: Nick Chen, MD | 206-292-2277 | nickc@seattlecancerwellness.com |
| United States, Washington | |
| Seattle Cancer Treatment and Wellness Center | Recruiting |
| Seattle, Washington, United States, 98112 | |
| Contact: Nick Chen, MD 206-292-2277 nickc@seattlecancerwellness.com | |
| Contact: Jerry Kaufman 206-292-2277 jerryk@seattelcancerwellness.com | |
| Principal Investigator: | Ben Chue, MD | Seattle Cancer Treatment and Wellness Center |
More Information
| Study ID Numbers: | CTCA06-02 |
| Study First Received: | May 5, 2006 |
| Last Updated: | May 7, 2007 |
| ClinicalTrials.gov Identifier: | NCT00323583 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cancer Pancreatic Cancer Cancer Alternative Therapies Living with Cancer |
|
Antimetabolites Immunologic Factors Pancreatic Neoplasms Leucovorin Oxaliplatin Vitamins Micronutrients Gemcitabine Endocrine Gland Neoplasms Digestive System Neoplasms Vitamin B Complex Endocrine System Diseases Trace Elements |
Antimitotic Agents Folinic Acid Immunosuppressive Agents Calcium, Dietary Digestive System Diseases Paclitaxel Fluorouracil Tubulin Modulators Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Antineoplastic Agents, Phytogenic |
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Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Leucovorin Oxaliplatin Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Endocrine Gland Neoplasms Digestive System Neoplasms |
Vitamin B Complex Growth Substances Mitosis Modulators Endocrine System Diseases Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Paclitaxel Fluorouracil Tubulin Modulators Pancreatic Diseases Antineoplastic Agents, Phytogenic |
