Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01013649

Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride and erlotinib hydrochloride to see how well they work compared with gemcitabine hydrochloride alone followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: capecitabine Drug: erlotinib hydrochloride Drug: fluorouracil Drug: gemcitabine hydrochloride Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Fluorouracil Gemcitabine Gemcitabine hydrochloride Capecitabine Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

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

Primary Outcome Measures:

Overall survival of patients treated with gemcitabine hydrochloride with vs without erlotinib hydrochloride (first randomization) [ Designated as safety issue: No ]
Overall survival of patients treated with chemotherapy with vs without radiotherapy (second randomization) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: Yes ]
Frequency of objective criteria of resectability as measured by preoperative imaging [ Designated as safety issue: No ]
Quality of life as measured by fatigue (FACIT-Fatigue and PROMIS-derived short form) [ Designated as safety issue: No ]
Laboratory correlative studies related to K-Ras in patients treated with gemcitabine hydrochloride with vs without erlotinib hydrochloride (first randomization) [ Designated as safety issue: No ]

Estimated Enrollment:	950
Study Start Date:	November 2009
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm I Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity.	Drug: gemcitabine hydrochloride Given IV
Experimental: Arm II Patients receive gemcitabine hydrochloride as in arm I and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity.	Drug: erlotinib hydrochloride Given orally Drug: gemcitabine hydrochloride Given IV
Experimental: Arm III Patients receive 1 course of the same treatment that they receive in arm I or II.	Drug: erlotinib hydrochloride Given orally Drug: gemcitabine hydrochloride Given IV
Experimental: Arm IV Patients receive 1 course of the same treatment that they receive in arm I or II. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5½ weeks (28 fractions). During radiotherapy, patients receive either oral capecitabine twice daily 5 days per week or fluorouracil IV continuously for 5½ weeks or until radiotherapy is completed.	Drug: capecitabine Given orally Drug: fluorouracil Given IV Drug: gemcitabine hydrochloride Given IV Radiation: 3-dimensional conformal radiation therapy Given for 5½ weeks (28 fractions) Radiation: intensity-modulated radiation therapy Given for 5½ weeks (28 fractions)

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Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary adenocarcinoma of the pancreatic head, neck, or uncinate process
- Intraductal papillary mucinous neoplasm or invasive adenocarcinoma allowed
- No non-adenocarcinoma, adenosquamous carcinoma, islet cell (neuroendocrine) tumor, cystadenoma, cystadenocarcinoma, carcinoid tumor, duodenal carcinoma, distal bile duct tumor, or ampullary carcinoma
Pathologic stage T1-3, N0-1, M0 disease according to AJCC 6th edition
Has undergone a potentially curative resection (i.e., removal of all gross tumor) involving a classic (Whipple) or a pylorus preserving pancreaticoduodenectomy within the past 21-56 days
- Operative report must contain a statement from the surgeon explicitly detailing that a total gross excision of the primary tumor was achieved
- Pathology report must include documentation of margin status, size of the tumor, and status of the 3 major surgical margins (bile duct, pancreatic parenchyma, and retroperitoneal [uncinate])
Post-resection serum CA19-9 ≤ 180 IU/L
Tumor tissue block and peripheral blood samples must be submitted to the study's central tumor bank for correlative studies
No recurrent pancreatic cancer

PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
Serum total bilirubin ≤ 2 times upper limit of normal (ULN)
Creatinine ≤ 2 times ULN
SGOT ≤ 2.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Suitable to receive study radiotherapy, as documented by a radiation oncologist
Active HIV infection allowed provided the CD4 count is ≥ 499/mm^3 and the viral load is ≤ 50 copies/mL
Total oral caloric intake ≥ 1,500 calories/day
No significant nausea and vomiting
None of the following severe active comorbidities that would preclude study therapy:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 3 months
- Acute bacterial or fungal infection requiring IV antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
No other invasive malignancies within the past 2 years except for nonmelanomatous skin cancer or carcinoma in situ

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior systemic chemotherapy for pancreatic cancer
- Prior chemotherapy for a different cancer allowed
No prior total pancreatectomy, distal pancreatectomy, or central pancreatectomy
No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
Concurrent highly active antiretroviral treatment (HAART) allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013649

Show 174 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Ross A. Abrams, MD

Rush University Medical Center

More Information

Additional Information:

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

Publications:

Goodman KA, Regine WF, Dawson LA, Ben-Josef E, Haustermans K, Bosch WR, Turian J, Abrams RA. Radiation Therapy Oncology Group Consensus Panel Guidelines for the Delineation of the Clinical Target Volume in the Postoperative Treatment of Pancreatic Head Cancer. Int J Radiat Oncol Biol Phys. 2012 Apr 5. [Epub ahead of print]

Responsible Party:	Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT01013649 History of Changes
Other Study ID Numbers:	CDR0000659092, RTOG-0848
Study First Received:	November 13, 2009
Last Updated:	May 23, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Gemcitabine
Capecitabine

Erlotinib
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 23, 2012