Erlotinib and Gemcitabine With or Without Panitumumab in Treating Patients With Metastatic Pancreatic Cancer
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer, Pancreatic Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2009 |
End Date: | May 2013 |
Randomized Phase II Trial of Panitumumab, Erlotinib and Gemcitabine vs. Erlotinib and Gemcitabine in Patients With Untreated, Metastatic Pancreatic Adenocarcinoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Panitumumab may also stop the
growth of pancreatic cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well giving panitumumab together
with gemcitabine and erlotinib works compared to giving gemcitabine and erlotinib alone in
treating patients with metastatic pancreatic cancer.
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Panitumumab may also stop the
growth of pancreatic cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well giving panitumumab together
with gemcitabine and erlotinib works compared to giving gemcitabine and erlotinib alone in
treating patients with metastatic pancreatic cancer.
OBJECTIVES:
Primary
- To assess whether the addition of panitumumab (a dual-epidermal growth factor receptor
inhibitor) to standard chemotherapy comprising gemcitabine hydrochloride and erlotinib
hydrochloride results in an improvement in overall survival of patients with previously
untreated, metastatic adenocarcinoma of the pancreas.
Secondary
- To compare objective response rates, progression-free survival, time to treatment
failure, quality of life, and adverse event rates in patients treated with these
regimens.
- To evaluate the downstream marker, KRAS, in stool specimens.
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance
status (0 vs 1) and prior adjuvant chemotherapy (yes vs no). The first 6 patients are
assigned to arm II. Subsequent patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and
15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28
days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive
2 additional courses of treatment; patients achieving a partial response (PR) receive
retreatment as above in the absence of disease progression or unacceptable toxicity.
Patients achieving a CR after 4 courses of treatment receive maintenance therapy
comprising erlotinib hydrochloride daily until the first disease progression. After the
first progression, patients are retreated with gemcitabine hydrochloride and erlotinib
hydrochloride until second progression (using the first progression tumor measurements
as the new baseline reference).
- Arm II: Patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in
arm I and panitumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days
for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of
treatment; patients achieving a PR receive retreatment as above in the absence of
disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses
of treatment receive maintenance therapy comprising erlotinib hydrochloride daily and
panitumumab every 2 weeks until the first disease progression. After the first
progression, patients are retreated with gemcitabine hydrochloride, erlotinib
hydrochloride, and panitumumab until second progression (using the first progression
tumor measurements as the new baseline reference).
Stool samples are collected at baseline and analyzed for KRAS mutations via protein
analyses.
Quality of life will be assessed at baseline, every 2 courses during treatment, and at the
end of treatment.
After the second progression, patients are followed every 3-6 months for 2 years.
Primary
- To assess whether the addition of panitumumab (a dual-epidermal growth factor receptor
inhibitor) to standard chemotherapy comprising gemcitabine hydrochloride and erlotinib
hydrochloride results in an improvement in overall survival of patients with previously
untreated, metastatic adenocarcinoma of the pancreas.
Secondary
- To compare objective response rates, progression-free survival, time to treatment
failure, quality of life, and adverse event rates in patients treated with these
regimens.
- To evaluate the downstream marker, KRAS, in stool specimens.
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance
status (0 vs 1) and prior adjuvant chemotherapy (yes vs no). The first 6 patients are
assigned to arm II. Subsequent patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and
15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28
days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive
2 additional courses of treatment; patients achieving a partial response (PR) receive
retreatment as above in the absence of disease progression or unacceptable toxicity.
Patients achieving a CR after 4 courses of treatment receive maintenance therapy
comprising erlotinib hydrochloride daily until the first disease progression. After the
first progression, patients are retreated with gemcitabine hydrochloride and erlotinib
hydrochloride until second progression (using the first progression tumor measurements
as the new baseline reference).
- Arm II: Patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in
arm I and panitumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days
for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of
treatment; patients achieving a PR receive retreatment as above in the absence of
disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses
of treatment receive maintenance therapy comprising erlotinib hydrochloride daily and
panitumumab every 2 weeks until the first disease progression. After the first
progression, patients are retreated with gemcitabine hydrochloride, erlotinib
hydrochloride, and panitumumab until second progression (using the first progression
tumor measurements as the new baseline reference).
Stool samples are collected at baseline and analyzed for KRAS mutations via protein
analyses.
Quality of life will be assessed at baseline, every 2 courses during treatment, and at the
end of treatment.
After the second progression, patients are followed every 3-6 months for 2 years.
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas (ductal or
undifferentiated)
- Metastatic disease
- No islet cell, acinar cell, or cystadenocarcinomas
- No locally advanced disease
- No history or known presence of CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 2 times upper limit of normal (ULN) (patients may be stented)
- AST ≤ 2.5 times ULN
- Creatinine ≤ 2.0 times ULN
- Magnesium ≥ lower limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to provide a stool specimen
- No malignancy diagnosed within the past 3 years except basal cell or squamous cell
skin cancer, prostate cancer (Gleason < 7), or carcinoma in situ of the cervix
- No uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements
- No clinically significant cardiovascular disease (i.e., myocardial infarction,
unstable angina, symptomatic congestive heart failure, or serious uncontrolled
cardiac arrhythmia) within the past year
- No known positive test(s) for HIV infection, hepatitis C virus, or acute or chronic
active hepatitis B infection
- No liver dysfunction from cirrhosis or viral hepatitis
- No enteral hyperalimentation
- No grapefruit or grapefruit juice during the study
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- More than 4 months since prior radiotherapy, immunotherapy, or biologic therapy
- More than 4 weeks since prior and no elective or planned major surgery
- More than 2 weeks since prior minor and no elective or planned surgery
- No prior cytotoxic chemotherapy for metastatic disease
- Adjuvant chemotherapy for completely resected disease or chemoradiotherapy for
locally advanced disease is allowed, provided it was administered > 6 months
prior to study entry
- Adjuvant chemotherapy must not have contained an EGFR inhibitor
- Gemcitabine hydrochloride used as either a radiosensitizer or as maintenance
therapy is allowed, provided more than 6 months have elapsed since the last day
of treatment
- No prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small
molecule EGFR inhibitors (e.g., gefitinib hydrochloride, erlotinib hydrochloride, or
lapatinib)
- No concurrent immunotherapy or radiotherapy
- No other concurrent chemotherapy
- No concurrent colony-stimulating factors during the first course of study therapy
We found this trial at
262
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Ann Arbor, Michigan 48106
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701 10th St SE
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Cedar Rapids, Iowa 52403
(319) 365-4673
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2222 N. Nevada Avenue
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Colorado Springs, Colorado 80907
(719) 776-5000
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Penrose Cancer Center at Penrose Hospital Through a full range of clinical trials, genetic counseling,...
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11850 Blackfoot St. NW
Suite 130
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
763-236-0808
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Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
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Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
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18101 Oakwood Blvd
Dearborn, Michigan 48124
Dearborn, Michigan 48124
(313) 593-8620
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Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
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St. Anthony Central Hospital The St. Anthony Medical Campus in Lakewood combines our heritage of...
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Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
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Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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1221 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-4141
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John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
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Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
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411 Laurel St New Visions
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3970
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Medical Oncology and Hematology Associates at Mercy Cancer Center When it comes to cancer care,...
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411 Laurel Street
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3121
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Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
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Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
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Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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Community Cancer Center When you have cancer, you might think first of treatments
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Hematology Oncology Center The Center for Hematology-Oncology was established in 1995 for the purpose of...
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Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
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Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
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Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
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Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
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Cancer Center of Kansas - Fort Scott Dr. H.E. Hynes founded Cancer Center of Kansas,...
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550 Osborne Road
Fridley, Minnesota 55432
Fridley, Minnesota 55432
763-236-5000
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Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
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Galesburg Clinic, PC OSF Galesburg Clinic, located on the OSF St. Mary Medical Center campus,...
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Illinois CancerCare - Galesburg Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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960 S. Columbia Rd.
Grand Forks, North Dakota 58201
Grand Forks, North Dakota 58201
701-780-5400
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Altru Cancer Center at Altru Hospital From chemotherapy and radiation therapy to personal holistic services,...
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2635 North 7th Street
Grand Junction, Colorado 81501
Grand Junction, Colorado 81501
970-298-CARE (2273)
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St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center St. Mary's Hospital...
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1101 26th Street South
Great Falls, Montana 59405
Great Falls, Montana 59405
406.455.5000
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Sletten Cancer Institute at Benefis Healthcare Benefis Hospitals has 516 beds at its two campuses...
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