Phase I/II Radiotherapy Dose Escalation Study in Locally Advanced Pancreatic Cancer, Using a Simultaneous Intensity Modulated Boost With Concurrent Gemcitabine
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase I/II Radiotherapy Dose Escalation Study in Locally Advanced Pancreatic Cancer, Using a Simultaneous Intensity Modulated Boost With Concurrent Gemcitabine
OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of intensity-modulated radiotherapy
delivered to the gross tumor volume when administered with gemcitabine hydrochloride in
patients with locally advanced pancreatic carcinoma. (Phase I)
- To define the dose-limiting toxicities of this regimen in these patients. (Phase I)
- To determine the local control in patients treated at the MTD (determined in phase I).
(Phase II)
- To compare the disease-free survival and time to progression in these patients with
that of historical controls. (Phase II)
OUTLINE: This is a multicenter phase I, dose-escalation study of intensity-modulated
radiotherapy, followed by a phase II study.
- Induction chemotherapy: Patients receive gemcitabine hydrochloride IV on days 1, 8, and
15. Treatment repeats every 28 days for 2 courses in the absence of disease progression
or unacceptable toxicity. Patients then undergo CT scan. Patients with no evidence of
metastatic disease proceed to chemoradiotherapy.
- Chemoradiotherapy: Beginning 1-2 weeks after completion of induction chemotherapy,
patients undergo intensity-modulated radiotherapy once daily 5 days a week and
gemcitabine hydrochloride IV over 30 minutes once weekly for 5 weeks in the absence of
disease progression or unacceptable toxicity. Patients whose disease remains
unresectable proceed to adjuvant chemotherapy.
- Adjuvant chemotherapy: Beginning 4-6 weeks after completion of chemoradiotherapy,
patients receive gemcitabine hydrochloride as in induction chemotherapy.
After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 2 years, and then annually thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Pathologically confirmed adenocarcinoma or poorly differentiated carcinoma of the
pancreas, ampulla of Vater, or distal bile duct
- Locally advanced disease
- Medically inoperable, unresectable, or borderline resectable disease
- No previously resected disease (i.e., status post-pancreaticoduodenotomy)
- No non-adenocarcinoma, adenosquamous carcinoma, islet cell carcinoma, cyst adenoma,
cystadenocarcinoma, carcinoid tumor, or duodenal carcinoma
- No lesions in the tail of the pancreas and/or splenic artery/vein
involvement/encasement
- No recurrent or metastatic (M1) disease
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- WBC > 3,000/μL
- Platelet count > 100,000/μL
- Bilirubin ≤ 2 mg/dL
- SGOT < 5 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Adequate oral nutrition (e.g., ≥ 1,500 calories/day, stable weight for ≥ 2 weeks, and
≤ 5% weight loss)
- No active malignancy within the past 3 years, except cervical carcinoma in situ or
nonmelanoma skin cancer that has been removed
- No severe, active comorbidity, including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring IV antibiotics at the time of
study registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization within the past month or precluding study therapy at
the time of study registration
- Active hepatitis, decompensated cirrhosis, or clinically significant liver
failure
- Other severe comorbid condition, as determined by the principal investigator
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy
- No prior radiotherapy to any upper abdominal site
- No concurrent prophylactic colony-stimulating factors during radiotherapy
- No concurrent warfarin
- No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy,
radiotherapy, surgery for cancer, or experimental therapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of intensity-modulated radiotherapy (Phase I)
Outcome Time Frame:
4 years
Safety Issue:
Yes
Principal Investigator
Salma Jabbour, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Institutional Review Board
Study ID:
CDR0000639635
NCT ID:
NCT00878657
Start Date:
April 2009
Completion Date:
March 2013
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage III pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
