Phase II Trial Of Induction Gemcitabine/CPT-11 Followed By Twice-Weekly Infusion Gemcitabine And Concurrent External Beam Radiation For The Treatment Of Locally Advanced Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase II Trial Of Induction Gemcitabine/CPT-11 Followed By Twice-Weekly Infusion Gemcitabine And Concurrent External Beam Radiation For The Treatment Of Locally Advanced Pancreatic Cancer
OBJECTIVES:
- Determine the time to progression, local control, and survival of patients with locally
advanced, unresectable pancreatic cancer treated with induction gemcitabine and
irinotecan followed by gemcitabine and concurrent radiotherapy.
OUTLINE: Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90
minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of
disease progression or unacceptable toxicity.
Within 2 weeks of completing induction chemotherapy, patients receive gemcitabine IV over
30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. Patients undergo concurrent
radiotherapy 5 days a week for 5.5 weeks.
Patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years.
PROJECTED ACCRUAL: Approximately 60-120 patients will be accrued for this study within 1-2
years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced pancreatic cancer
- Regional (peri-pancreatic) lymph node involvement allowed
- Clinically or surgically staged and considered unresectable or inoperable
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 6 months
Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Hemoglobin at least 10 g/dL
- Platelet count at least 100,000/mm3
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- Not pregnant
- Fertile patients must use effective contraception
- No other concurrent or prior malignancy within the past 2 years except nonmelanoma
skin cancer or in situ carcinoma of the cervix or breast
- No other serious medical or psychiatric illness that would preclude giving informed
consent or limit survival to less than 2 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent anticancer immunotherapy
Chemotherapy:
- No prior chemotherapy
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- No concurrent anticancer hormonal therapy
Radiotherapy:
- No prior abdominal-pelvic radiotherapy
- No other concurrent anticancer radiotherapy
Surgery:
- See Disease Characteristics
- At least 3 weeks since prior open abdominal surgery
- More than 10 days since prior laparoscopy
Other:
- No other concurrent investigational drug
- No concurrent participation in other clinical study
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Arthur William Blackstock, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Federal Government
Study ID:
CDR0000068933
NCT ID:
NCT00025168
Start Date:
November 2001
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage III pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Greenville Hospital System | Greenville, South Carolina 29605 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Southeastern Medical Oncology Center | Goldsboro, North Carolina 27534 |
| Spartanburg Regional Healthcare System | Spartanburg, South Carolina 29303 |
