Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer (GECA)
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ClinicalTrials.gov Identifier: NCT01303029 |
Recruitment Status :
Completed
First Posted : February 24, 2011
Last Update Posted : August 1, 2017
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Pancreatic Cancer | Drug: Gemcitabine+erlotinib Drug: Gemcitabine+erlotinib+capecitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Control
Gemcitabine+erlotinib
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Drug: Gemcitabine+erlotinib
Gemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks . |
Experimental: Experimental
Gemcitabine+erlotinib+capecitabine
|
Drug: Gemcitabine+erlotinib+capecitabine
Gemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Capecitabine will be administered orally 1.660 mg/m2 day from day 1 to day 21. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks . |
- Progression free survival [ Time Frame: 4 years ]
- Overall survival [ Time Frame: 4 years ]
- Response rate (RR) [ Time Frame: 4 years ]
- Duration of response [ Time Frame: 4 years ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 years ]
- Percentage of rash in patients treated with erlotinib and progression free survival and overall survival and treatment relationship [ Time Frame: 4 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ability to understand and willingness to sign a written informed consent
- Able, in the investigator's opinion, to fulfill the procedures and explorations of the study
- Age ≥ 18 years old
- ECOG 0-2
- Life expectancy ≥ 12 weeks
- Patients with metastatic adenocarcinoma of the pancreas, following 7th edition of TNM classification
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
- Measurable disease following RECIST criteria version 1.1
- No previous systemic treatment for metastatic pancreatic cancer Adjuvant chemotherapy al least 6 months before enrollment is allowed. Patients having neoadjuvant chemotherapy must have completed the treatment at least 4 weeks before trial entry. Toxicities associated to previous treatment must be resolved before enrollment. Progression disease (metastatic disease) must be confirmed after adjuvant treatment
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Adequate bone marrow function as determined by:
- Hemoglobin: ≥ 9 g/dL. (patients with hemoglobin < 9 g/dL could be transfused before their inclusion on the study)
- Platelets: ≥ 100 x 109/L
- Absolute Neutrophil account (ANC) ≥ 1,5 x 109/L
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Adequate liver function, as determined by:
- Serum bilirubin ≤ 1,5 x LSN
- AST, ALT ≤ 2,5 x LSN in patients without liver metastasis. In patients with liver metastasis ≤ 5 x LSN
- Alkaline phosphatase ≤ 2,5 x LSN or ≤ 5 x LSN in patients with liver metastasis. In patients with bone metastasis ≤ 10 x LSN
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Adequate renal function, as determined by:
- Creatinine clearance using the Cockcroft-Gault formula ≥ 50.0 ml/min
- Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to randomization. Postmenopausal women are defined as those who have been amenorrheic for at least 12 months. Also, both men and women enrolled in this study must use adequate birth control (eg., abstinence, intrauterine device, oral contraceptive or double barrier method or be surgically sterile), starting at the signing of the informed consent and up to at least 6 months after completion of treatment or the last dose, whichever occurs first
- Patients must not have undergone a major surgical procedure within 4 weeks prior to study treatment. The surgical wound should be completely healed
Exclusion Criteria:
- Local pancreatic cancer (stage IA-IIB) or locally advance cancer (stage III), following the TNM 7th edition classification. Patients with metastatic disease that relapse after the initial diagnosis of local or advance disease could be included in this study
- Pancreatic endocrine tumor and ampulloma
- Evidence of carcinomatosis meningitis or brain metastasis. In case of clinical suspicious of brain metastasis is mandatory to perform a brain TAC/MR 4 weeks prior de inclusion.
- Primary tumors developed 5 years previous to the inclusion, except in situ cervix carcinoma or skin basocellular cancer properly treated
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Cardiovascular disease clinically significant (active):
- Non-controlled arterial hypertension (Systolic pressure > 150 mg Hg and/or diastolic pressure > 100 mm Hg on repeated pressure measurements)
- Cerebrovascular accident/ictus (≤ 6 weeks prior to inclusion)
- Myocardial infarction (≤ 6 months prior to inclusion)
- Unstable angina
- Congestive cardiac insufficiency (grade II or superior following to New York Heart Association (NYHA)
- Severe cardiac arrythmia requiring treatment
- Significant ophthalmologic anomalies
- Deficit in Dihydropyrimidine-Dehydrogenase (DPD)
- Unable to take oral drug. Previous surgical process that affect the absorption or make the needed to have intravenous feeding or parenteral nutrition with lipids
- Pregnancy women or in lactation period
- Antineoplastic treatment (chemotherapy, hormonal treatment, radiotherapy, surgery, biological therapy or tumor embolization) 4 weeks prior the inclusion
- Previous treatment with capecitabine or EGFR inhibitor
- Metabolic disease or any other disease which, in the investigator's opinion, might interfere with the treatment in study
- Known hypersensibility to any study drug (gemcitabine, erlotinib, capecitabine) or to 5-fluorouracile and fluoropyrimidines
- Current infection grade ≥ 2 (CTCAE)
- Known human immunodeficiency virus infection, or chronic infection with hepatitis B or C virus, or severe uncontrolled intercurrent infection or other severe uncontrolled concomitant diseases
- Medical, psychological, psychiatric or sociological conditions that would interfere to the patient participation in the study or in the assessment of the results
- Current or 30 days previous to study treatment with other investigational drug or participation in other trial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303029
Spain | |
Spanish Cooperative Group for Digestive Tumour Therapy | |
Madrid, Spain, 28046 |
Study Chair: | Antonio Irigoyen, MD | Hospital de Toledo, Spain | |
Study Chair: | Manuel Benavides, MD | Hospital Carlos Haya, Málaga. Spain |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) |
ClinicalTrials.gov Identifier: | NCT01303029 |
Other Study ID Numbers: |
TTD-10-01 2010-022599-30 ( EudraCT Number ) |
First Posted: | February 24, 2011 Key Record Dates |
Last Update Posted: | August 1, 2017 |
Last Verified: | July 2017 |
Pancreatic cancer gemcitabine erlotinib capecitabine |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine |
Capecitabine Erlotinib Hydrochloride Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors |