Combination Chemotherapy, Radiation Therapy, and Interferon Alfa in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery - Full Text View

Sponsors and Collaborators:	Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00262951

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Biological: recombinant interferon alfa Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Radiation Therapy Surgery

Drug Information available for: Fluorouracil Cisplatin Interferon alfa-2a Interferon alfa-n1 Interferons

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Tumor response, in terms of resectability, as measured by CT scan at 2 weeks after completion of each course [ Designated as safety issue: No ]

Estimated Enrollment:	43
Study Start Date:	January 2005
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262951

Locations

United States, Minnesota
Masonic Cancer Center at University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

Investigators

Study Chair:

Edward W. Greeno, MD

Masonic Cancer Center, University of Minnesota

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Masonic Cancer Center at University of Minnesota ( Edward W. Greeno )
Study ID Numbers:	CDR0000450851, UMN-2004LS060, UMN-2743RO
Study First Received:	December 6, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00262951 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Pancreatic Neoplasms
Pancrelipase
Cisplatin
Phenylephrine
Endocrine Gland Neoplasms
Interferon-alpha
Digestive System Neoplasms
Interferons
Adjuvants, Immunologic

Endocrine System Diseases
Antiviral Agents
Angiogenesis Inhibitors
Immunosuppressive Agents
Oxymetazoline
Digestive System Diseases
Fluorouracil
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Interferon Alfa-2a
Adenocarcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Interferon Type I, Recombinant
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Endocrine Gland Neoplasms

Interferon-alpha
Digestive System Neoplasms
Growth Substances
Interferons
Endocrine System Diseases
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Pancreatic Diseases
Interferon Alfa-2a

ClinicalTrials.gov processed this record on August 30, 2009