Randomized multicenter phase III study in patients with locally advanced adenocarcinoma of the pancreas: gemcitabine with or without chemoradiotherapy and with or without erlotinib
Phase III study to determine the role of radiotherapy in patients with locally advanced pancreatic cancer: gemcitabine with and without chemoradiotherapy and with or without erlotinib
Australasian Gastro-Intestinal Trial Group (AGITG)
60 participants
Jul 15, 2010
Interventional
Conditions
Summary
This study is looking at three main questions about the treatment of patients with locally advanced cancer of the pancreas. Firstly, does taking erlotinib tablets in addition to the usual gemcitabine chemotherapy make a difference? Secondly, after 15 weeks of chemotherapy (plus or minus erlotinib), is it better to switch to chemoradiotherapy (radiotherapy plus capecitabine tablets) for 6 weeks, or is it better to continue the same gemcitabine chemotherapy (plus or minus erlotinib) for 6 more weeks? Thirdly, does it make any difference to keep taking erlotinib tablets after the 15 + 6 weeks of treatment have finished? Who is it for? You can join this study if you have locally advanced cancer of the pancreas which has not spread to distant sites, and is not suitable for surgery. There are some more specific requirements, but your study doctor will discuss these with you. Trial details. All patients will commence treatment with 15 weeks of weekly intravenous gemcitabine. Depending on a random assignment, some patients will also take daily erlotinib tablets during those 15 weeks. If there is no disease progression, some patients will be randomly assigned to continue the same treatment for another 6 weeks, while other patients will be randomly assigned to switch to 6 weeks of chemoradiotherapy (radiotherapy on weekdays plus capecitabine tablets every day). If there is no disease progression, all patients who at either stage were assigned to take erlotinib tablets will then keep taking erlotinib until disease progression, for a minimum 17 months. Patients who were never assinged to take erlotinib tablets will just be followed up for a minimum 17 months. Participants will be assessed using the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS), blood tests, physical examination and computer topography (CT) scans of the abdomen and chest.
Eligibility
Inclusion Criteria20
- Age older than 18yrs.
- Patients with de novo locally advanced, histologically proven adenocarcinoma of the
- pancreas without distant metastases (stage III according to the International Union against Cancer (UICC) classification) and
- not considered for curative resection after pluridisciplinary discussion.
- Eastern Cooperative Oncology Group (ECOG) Performance Status no less then 2
- Estimated life expectancy greater then 12 weeks
- No prior radiotherapy nor chemotherapy for any reason
- Signed informed consent form
- Polynuclear neutrophils = 1.5 x 109/L, platelets = 100 x 109/L and hemoglobin = 9 g/dL
- Total bilirubin smaller or equal to 1.5 N (N: upper limit of normal). In patients who have had a recent
- biliary drain and whose bilirubin is descending, a value of smaller or equal to 3 N (50 µmoles/L) is
- acceptable.
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) smaller or equal to 2.5 N, alkaline phosphatase smaller or equal to 5 N
- Albumin = 25 g/L
- Creatinin £ 177 mmol/L (2 mg/dL)
- Female patients who are not menopausal and their partners must accept to use effective
- contraception throughout treatment and for 3 months after the end of treatment. All
- patients who are capable of becoming pregnant must take a pregnancy test which is
- negative within 72 hours before beginning treatment. The definition of effective
- contraception is left up to the decision of the investigator.
Exclusion Criteria17
- Localized stage IA to IIB or metastatic cancer (stage IV) according to UICC
- Previous chemotherapy for any reason
- Previous abdominal radiotherapy
- Allergy to one of ingredients in erlotinib
- Prior treatment with an anti-EGFR
- Cancer within the 5 years before inclusion, except for in situ cancer of the neck of the
- uterus or basal cell skin cancer.
- Severe infection
- Ophthalmic disease (inflammation, keratopathy or infection)
- Symptomatic coronary or cardiac insufficiency, myocardial infarction or stroke within the
- last 6 months.
- Unable to take oral treatments or with gastrointestinal disorders that could be associated
- with absorption disorders, untreated gastric or duodenal ulcer.
- Pregnancy or breast feeding
- Unable to follow for psychological, familial or geographic reasons.
- Not affiliated with a social security regime.
- Diarrhea = grade 2 and/or uncontrolled diarrhoea
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Interventions
Gemcitabine 1000mg/m2 30 minutes infusion on days 1,8,15,22,29,36,43, after first evaluation continue gemcitabine on days 57,64,71,85,92,99 and erlotinib 100mg dose per day for 4 months then 150 mg/day, orally, as maintanence therapy, for two years (end of study). Should the tumour NOT increase in size and/or spread to surrounding structure, then patients are FURTHER either randomised to 1) continuing with chemoradiation (radiation 54 Gy and 2x800mg/m2 of Capecitabine, orally, 5 days a week, over 6 weeks) and erlotinib maintenance (after 1 month break from completion of chemoradiation, patients will take 150mg of erlotinib orally, for 2 years, stopping erlotinib maintanence, if tumour increases in size or spread to surrounding structure) or 2) just erlotinib (100mg dose per day, orally, for 2 months) .
Locations(1)
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ACTRN12609000158268