Combination Chemotherapy, Radiation Therapy, and Interferon Alfa in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: cisplatin (Drug); fluorouracil (Drug); recombinant interferon alfa (Drug); adjuvant therapy (Procedure); conventional surgery (Procedure); neoadjuvant therapy (Procedure); radiation therapy (Procedure)
Phase: Phase 2
Status: Recruiting
Sponsored by: Masonic Cancer Center, University of Minnesota Official(s) and/or principal investigator(s):
Edward W. Greeno, MD, Study Chair, Affiliation: Masonic Cancer Center, University of Minnesota
Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Radiation therapy uses high-energy x-rays to kill tumor cells. Interferon alfa may interfere
with the growth of tumor cells. Giving combination chemotherapy and radiation therapy
together with interferon alfa before surgery may shrink the tumor so it can be removed.
Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy and
radiation therapy together with interferon alfa works in treating patients with locally
advanced pancreatic cancer that cannot be removed by surgery.
Clinical Details
Official title: A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma
Study design: Treatment
Primary outcome: Tumor response, in terms of resectability, as measured by CT scan at 2 weeks after completion of each course
Detailed description:
OBJECTIVES:
Primary
- Determine the effect of neoadjuvant chemoradiotherapy and interferon alfa on converting
patients with locally advanced unresectable adenocarcinoma of the pancreas to
resectability.
Secondary
- Determine the rate and severity of early and late toxic effects of these regimens in
these patients.
- Improve surgical morbidity profile and overall survival of patients who undergo surgical
resection.
- Determine overall and progression-free survival of patients treated with this regimen.
OUTLINE: This is an pilot, multicenter study.
- Part 1 (neoadjuvant therapy): Patients receive fluorouracil IV continuously over 24
hours on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and
interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29,
31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26,
29-33, and 36-38. Patients then undergo restaging. Patients with resectable disease
undergo surgery, and 4-10 weeks later, proceed to part 2. Patients with unresectable
disease proceed directly to part 2, 4 weeks after completion of neoadjuvant therapy.
- Part 2 (chemotherapy): Patients receive fluorouracil IV on days 1, 8, 15, 22, 29, and
36. Treatment repeats every 56 days for up to 2 courses in the absence of disease
progression or unacceptable toxicity. Patients with unresectable disease undergo
restaging after each course of fluorouracil. If the tumor subsequently becomes
resectable, patients then undergo surgery.
After completion of study treatment, patients are followed periodically for 5 years and then
annually thereafter.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Newly diagnosed adenocarcinoma of the pancreas
- Diagnosed within the past 60 days
- Locally advanced, unresectable disease
- Stage TX-4, N0-1, M0 disease by CT scan and endoscopic ultrasound
- The following cell types are not eligible:
- Adenosquamous carcinoma
- Ampullary carcinoma
- Carcinoid tumor
- Cystadenocarcinoma
- Cystadenoma
- Distal common bile duct carcinoma
- Duodenal carcinoma
- Islet cell carcinoma
- No metastases by CT scan of the chest and endoscopic ultrasound and CT scan or MRI of
the abdomen and pelvis
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-1 OR
- Zubrod 0-1
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin > 9. 5 g/dL
- WBC > 3,000/mm^3
Hepatic
- AST and ALT < 4 times upper limit of normal (ULN)
- Bilirubin ≤ 3 mg/dL
- Alkaline phosphatase < 2 times ULN
Renal
- Creatinine < 1. 5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated nonmelanoma skin
cancer or carcinoma in situ of the cervix or breast
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior chronic immunotherapy (e. g., prednisone or methotrexate) for collagen
vascular disease or other chronic immunologic abnormality
- No concurrent interleukin-11 (Oprelvekin)
- No other concurrent biological response modifiers for pancreatic cancer
Chemotherapy
- No prior chemotherapy for pancreatic cancer
- No concurrent aminoglycoside antibiotics during cisplatin therapy
Endocrine therapy
- No concurrent dexamethasone
Radiotherapy
- No prior radiotherapy for pancreatic cancer
Other
- No concurrent halogenated antiviral agents during fluorouracil therapy
- No other concurrent systemic or locoregional therapy for pancreatic cancer
- No other concurrent investigational drugs
Locations and Contacts
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Clinical Trials Office - Masonic Cancer Center at University o, Phone: 612-624-2620
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2005
Last updated: October 24, 2008
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