Combination Chemotherapy, Intensity-Modulated Radiation Therapy, and Surgery in Treating Patients With Localized Pancreatic Cancer That Can Be Removed by Surgery - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00609336

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with intensity-modulated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to 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 together with intensity-modulated radiation therapy and surgery works in treating patients with localized pancreatic cancer that can be removed by surgery.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: capecitabine Drug: docetaxel Drug: gemcitabine hydrochloride Drug: oxaliplatin Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: intensity-modulated radiation therapy	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer Radiation Therapy Surgery

Drug Information available for: Oxaliplatin Gemcitabine Docetaxel Gemcitabine hydrochloride Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma

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

Primary Outcome Measures:

Median overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

1- and 2-year survival rate [ Designated as safety issue: No ]
Median recurrence-free survival following pancreaticoduodenectomy [ Designated as safety issue: No ]
Clinical response rate to induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
Pathologic response rate to induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
Biochemical response rate (CA 19-9 tumor marker) to induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
Surgical completion rate and complication rate following induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To assess the median overall survival of patients with resectable, localized adenocarcinoma of the pancreas treated with induction chemotherapy comprising gemcitabine hydrochloride, docetaxel, and capecitabine and neoadjuvant chemoradiotherapy comprising capecitabine, oxaliplatin, and intensity-modulated radiotherapy followed by surgical resection and adjuvant chemotherapy comprising gemcitabine hydrochloride and oxaliplatin.

Secondary

To determine the 1- and 2-year survival rate in patients treated with this regimen.
To determine the median recurrence-free survival following pancreaticoduodenectomy.
To determine the clinical response rate to induction chemotherapy and neoadjuvant chemoradiotherapy.
To determine the pathologic response rate to induction chemotherapy and neoadjuvant chemoradiotherapy.
To determine the CA 19-9 tumor marker response rate to induction chemotherapy and neoadjuvant chemoradiotherapy.
To determine the surgical completion rate and complication rate following induction chemotherapy and neoadjuvant chemoradiotherapy.
To determine the frequency and severity of toxicities associated with this regimen.

OUTLINE: This is a multicenter study.

Induction chemotherapy: Patients receive gemcitabine hydrochloride IV over 75 minutes and docetaxel IV over 30 minutes on days 4 and 11. Patients also receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Neoadjuvant chemoradiotherapy: Beginning no more than 14 days after completion of induction chemotherapy, patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Patients also undergo intensity-modulated radiotherapy daily on days 1-5 and 8-12 (total of 10 fractions).
Surgical resection: Approximately 2-6 weeks after completion of neoadjuvant chemoradiotherapy, patients undergo pancreaticoduodenectomy or "Whipple" procedure with or without preservation of the pylorus and proximal duodenum or a distal pancreatectomy with or without splenectomy.
Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive gemcitabine hydrochloride alone IV over 100 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Localized disease (T1-T3, N0-N1, M0 disease) as determined by helical multi-phase CT scan and/or endoscopic ultrasound according to published guidelines (AJCC 6th Ed.)
- Resectable or borderline resectable disease as determined by the treating surgeon and published guidelines (National Comprehensive Cancer Network v2.2006)
  - No permanently unresectable adenocarcinoma of the pancreas

PATIENT CHARACTERISTICS:

ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
Leukocyte count ≥ 3,000/μL
Absolute neutrophil count ≥ 1,500/μL
Platelet count ≥ 100,000/μL
Total bilirubin normal
AST/ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 1.5 times ULN if alkaline phosphatase > 2.5 times ULN)
Creatinine ≤ 2.0 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to swallow and retain oral medication
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine hydrochloride, docetaxel, capecitabine, oxaliplatin, or other agents used in the study
No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

No prior therapy for pancreatic cancer, including chemotherapy and radiotherapy
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents
No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609336

Locations

United States, Washington
Seattle Cancer Care Alliance	Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Samuel Whiting, MD, PhD

Fred Hutchinson Cancer Research Center

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:	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium ( Samuel Whiting )
Study ID Numbers:	CDR0000586450, FHCRC-6511, UWCC-UW-6511, UWCC-07-7286-H/B
Study First Received:	February 6, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00609336 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Adjuvants, Immunologic
Endocrine System Diseases
Immunosuppressive Agents
Antiviral Agents
Pancrelipase

Docetaxel
Oxaliplatin
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Capecitabine
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Oxaliplatin
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009