A Randomized Phase II Trial of Weekly Gemcitabine, Paclitaxel and External Irradiation (50.4 GY) Followed by the Farnesyl Transferase Inhibitor R115777 (NSC #702818) for Locally Advanced Pancreatic Cancer
N/A
N/A
Both
Adenocarcinoma of the Pancreas, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer
Trial Information
A Randomized Phase II Trial of Weekly Gemcitabine, Paclitaxel and External Irradiation (50.4 GY) Followed by the Farnesyl Transferase Inhibitor R115777 (NSC #702818) for Locally Advanced Pancreatic Cancer
OBJECTIVES:
I. Compare the 1-year survival rate in patients with locally advanced pancreatic cancer
treated with paclitaxel, gemcitabine, and radiotherapy with or without tipifarnib.
II. Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in
these patients.
III. Determine the feasibility and toxicity of prolonged administration of tipifarnib after
chemoradiotherapy in these patients.
IV. Determine whether tipifarnib administered after chemoradiotherapy can increase
progression-free and overall survival in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
weight loss in the preceding 6 months (more than 10% vs 10% or less) and tumor dimension (at
least 5 cm vs less than 5 cm). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on
day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on
days 1, 8, 15, 22, 29, and 36.
Arm II: Patients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion
of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice
daily for 21 days.
Treatment continues every 28 days in the absence of disease progression or unacceptable
toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
Inclusion Criteria:
- Histologically confirmed unresectable, locally advanced adenocarcinoma of the
pancreas
- Residual disease after resection (R1 or R2, microscopic or macroscopic) allowed
- No metastases in major viscera
- No peritoneal seeding or ascites
- Biliary or gastroduodenal obstruction must have drainage before starting study
therapy
- Radiographically assessable disease encompassable within a single irradiation field
(15 by 15 cm maximum)
- Performance status - Zubrod 0-1
- Granulocyte count at least 1,800/mm^3
- Platelet count at least 100,000/mm^3
- ALT less than 3 times upper limit of normal
- Bilirubin less than 2.0 mg/dL
- Creatinine less than 3.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 2 years except non-melanoma skin cancer or
carcinoma in situ of the cervix, uterus, or bladder
- No significant infection or other medical condition that would preclude study
- No prior chemotherapy (including gemcitabine or paclitaxel) for pancreatic cancer
- No other concurrent cytotoxic agents
- See Disease Characteristics
- No prior radiotherapy to the planned field
- No other concurrent radiotherapy
- See Disease Characteristics
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Description:
Calculated along with associated 95% confidence intervals.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Tyvin Rich
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radiation Therapy Oncology Group
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02423
NCT ID:
NCT00026104
Start Date:
November 2001
Completion Date:
Related Keywords:
- Adenocarcinoma of the Pancreas
- Stage II Pancreatic Cancer
- Stage III Pancreatic Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Radiation Therapy Oncology Group | Philadelphia, Pennsylvania 19107 |
