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
This study is currently recruiting participants.
Verified March 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01013649
First received: November 13, 2009
Last updated: March 18, 2013
Last verified: March 2013
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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. 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
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Pancreas Stage I Pancreatic Cancer Stage II Pancreatic Cancer |
Drug: gemcitabine hydrochloride Drug: erlotinib hydrochloride Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy Drug: capecitabine Drug: fluorouracil Procedure: quality-of-life assessment Other: laboratory biomarker analysis |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment 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:
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 (first randomization) [ Time Frame: From the date of first randomization (gemcitabine vs. gemcitabine/erlotinib) to the date of death or last follow-up, assessed up to 11 years ] [ Designated as safety issue: No ]Overall survival will be estimated by the Kaplan-Meier method. The distribution of overall survival estimates between the two arms for both primary endpoint questions will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with overall survival.
- Overall survival (second randomization) [ Time Frame: From the date of second randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up, assessed up to 11 years ] [ Designated as safety issue: No ]Overall survival will be estimated by the Kaplan-Meier method. The distribution of overall survival estimates between the two arms for both primary endpoint questions will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with overall survival.
Secondary Outcome Measures:
- Disease-free survival [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]Disease-free survival will be estimated by the Kaplan-Meier method.
- Adverse events assessed according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 11 years ] [ Designated as safety issue: Yes ]
- Frequency of objective criteria of resectability as measured by preoperative imaging [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 950 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | August 2020 (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
Other Names:
Drug: erlotinib hydrochloride
Given orally
Other Names:
Radiation: 3-dimensional conformal radiation therapy
Given for 5½ weeks (28 fractions)
Other Names:
Radiation: intensity-modulated radiation therapy
Given for 5½ weeks (28 fractions)
Other Name: IMRT
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies
|
|
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: gemcitabine hydrochloride
Given IV
Other Names:
Drug: erlotinib hydrochloride
Given orally
Other Names:
Radiation: 3-dimensional conformal radiation therapy
Given for 5½ weeks (28 fractions)
Other Names:
Radiation: intensity-modulated radiation therapy
Given for 5½ weeks (28 fractions)
Other Name: IMRT
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies
|
|
Experimental: Arm III
Patients receive 1 course of the same treatment that they receive in arm I or II.
|
Drug: gemcitabine hydrochloride
Given IV
Other Names:
Drug: erlotinib hydrochloride
Given orally
Other Names:
Radiation: 3-dimensional conformal radiation therapy
Given for 5½ weeks (28 fractions)
Other Names:
Radiation: intensity-modulated radiation therapy
Given for 5½ weeks (28 fractions)
Other Name: IMRT
Other: laboratory biomarker analysis
Correlative studies
|
|
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 5.5 weeks (28 fractions). During radiotherapy, patients receive either oral capecitabine twice daily 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed.
|
Drug: gemcitabine hydrochloride
Given IV
Other Names:
Drug: erlotinib hydrochloride
Given orally
Other Names:
Radiation: 3-dimensional conformal radiation therapy
Given for 5½ weeks (28 fractions)
Other Names:
Radiation: intensity-modulated radiation therapy
Given for 5½ weeks (28 fractions)
Other Name: IMRT
Drug: capecitabine
Given orally
Other Names:
Drug: fluorouracil
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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 American Joint Committee on Cancer (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
- 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
- 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 295 Study Locations
Show 295 Study LocationsSponsors and Collaborators
Investigators
| Principal Investigator: | Ross Abrams | Radiation Therapy Oncology Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01013649 History of Changes |
| Other Study ID Numbers: | NCI-2011-01987, RTOG 0848, U10CA021661 |
| Study First Received: | November 13, 2009 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous 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 |
ClinicalTrials.gov processed this record on May 23, 2013