Status:
UNKNOWN
Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer
Lead Sponsor:
Seattle Cancer Treatment and Wellness Center
Conditions:
Adenocarincoma of Pancreas
Stage III Pancreatic Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 sto...
Detailed Description
OBJECTIVES: * 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 ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS
- Patients with pathologically-proven pancreatic adenocarcinoma, who
- are not candidate for surgery
- are not candidate for radiation therapy and
- have failed gemcitabine-based chemotherapy regimen
- Gender Eligible for Study:
- Both
- 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:
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00323583
Start Date
May 1 2006
Last Update
May 8 2007
Active Locations (1)
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1
Seattle Cancer Treatment and Wellness Center
Seattle, Washington, United States, 98112