Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer

NCT00323583 | Unknown Phase 2

• 1 other identifier: CTCA06-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenocarincoma of Pancreas; Stage III Pancreatic Cancer; Stage IVA Pancreatic Cancer; Stage IVB Pancreatic Cancer

Keywords

Cancer; Pancreatic Cancer; Cancer Alternative Therapies; Living with Cancer

Outcome Measures

Primary Outcomes (6)

• Clinical response rate (PS improvement by ECOG score, analgesic dose reduction)

• Response Rate Recist (Uni-Dimensional) Criteria

• Progression free survival

• Median survival

• Overall survival

• Quality of life

Secondary Outcomes (1)

• Tolerance and Safety NCI-CTC version 2

Interventions

paclitaxel DRUG

oxaliplatin DRUG

leucovorin DRUG

5-fluorouracil DRUG

glutathione DRUG

calcium and magnesium DRUG

Chemotherapy PROCEDURE

Chemoprotection PROCEDURE

Complementary and alternative therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Performance state \>=3
• Uncontrolled serious concomitant disease
• Radiotherapy within the 6 weeks before Cycle 1' Day 1
• Surgery within the 2 weeks before Cycle 1' Day 1

Sponsors & Collaborators

• Seattle Cancer Treatment and Wellness Center: lead

Study Sites (1)

Seattle Cancer Treatment and Wellness Center

Seattle, Washington, 98112, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Paclitaxel; Oxaliplatin; Leucovorin; Fluorouracil; Glutathione; Calcium; Magnesium; Drug Therapy; Complementary Therapies

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Metals, Light; Therapeutics

Study Officials

• Ben Chue, MD

  Seattle Cancer Treatment and Wellness Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ben Chue, MD

CONTACT

206-292-2277

Nick Chen, MD

CONTACT

206-292-2277; nickc@seattlecancerwellness.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: May 1, 2006
• Last Updated: May 8, 2007

Record last verified: 2007-05

Locations

US (1)