Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer (GECA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01303029
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Tracking Information
First Submitted Date  ICMJE February 16, 2011
First Posted Date  ICMJE February 24, 2011
Last Update Posted Date August 1, 2017
Study Start Date  ICMJE February 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
Progression free survival [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01303029 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer
Official Title  ICMJE A Phase IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer
Brief Summary The purpose of the study is to evaluate the efficacy of the combination of gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic pancreatic cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE
  • 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 .
  • 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 .
Study Arms  ICMJE
  • Active Comparator: Control
    Gemcitabine+erlotinib
    Intervention: Drug: Gemcitabine+erlotinib
  • Experimental: Experimental
    Gemcitabine+erlotinib+capecitabine
    Intervention: Drug: Gemcitabine+erlotinib+capecitabine
Publications * Irigoyen A, Gallego J, Guillén Ponce C, Vera R, Iranzo V, Ales I, Arévalo S, Pisa A, Martín M, Salud A, Falcó E, Sáenz A, Manzano Mozo JL, Pulido G, Martínez Galán J, Pazo-Cid R, Rivera F, García García T, Serra O, Fernández Parra EM, Hurtado A, Gómez Reina MJ, López Gomez LJ, Martínez Ortega E, Benavides M, Aranda E; Spanish Cooperative Group of Treatment of Digestive Tumors (TTD). Gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in the first-line treatment of patients with metastatic pancreatic cancer: Efficacy and safety results of a phase IIb randomised study from the Spanish TTD Collaborative Group. Eur J Cancer. 2017 Apr;75:73-82. doi: 10.1016/j.ejca.2016.12.032. Epub 2017 Mar 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ability to understand and willingness to sign a written informed consent
  2. Able, in the investigator's opinion, to fulfill the procedures and explorations of the study
  3. Age ≥ 18 years old
  4. ECOG 0-2
  5. Life expectancy ≥ 12 weeks
  6. Patients with metastatic adenocarcinoma of the pancreas, following 7th edition of TNM classification
  7. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
  8. Measurable disease following RECIST criteria version 1.1
  9. 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
  10. 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
  11. 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
  12. Adequate renal function, as determined by:

    • Creatinine clearance using the Cockcroft-Gault formula ≥ 50.0 ml/min
  13. 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
  14. 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:

  1. 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
  2. Pancreatic endocrine tumor and ampulloma
  3. 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.
  4. Primary tumors developed 5 years previous to the inclusion, except in situ cervix carcinoma or skin basocellular cancer properly treated
  5. 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
  6. Significant ophthalmologic anomalies
  7. Deficit in Dihydropyrimidine-Dehydrogenase (DPD)
  8. 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
  9. Pregnancy women or in lactation period
  10. Antineoplastic treatment (chemotherapy, hormonal treatment, radiotherapy, surgery, biological therapy or tumor embolization) 4 weeks prior the inclusion
  11. Previous treatment with capecitabine or EGFR inhibitor
  12. Metabolic disease or any other disease which, in the investigator's opinion, might interfere with the treatment in study
  13. Known hypersensibility to any study drug (gemcitabine, erlotinib, capecitabine) or to 5-fluorouracile and fluoropyrimidines
  14. Current infection grade ≥ 2 (CTCAE)
  15. 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
  16. Medical, psychological, psychiatric or sociological conditions that would interfere to the patient participation in the study or in the assessment of the results
  17. Current or 30 days previous to study treatment with other investigational drug or participation in other trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01303029
Other Study ID Numbers  ICMJE TTD-10-01
2010-022599-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study Sponsor  ICMJE Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Study Chair: Antonio Irigoyen, MD Hospital de Toledo, Spain
Study Chair: Manuel Benavides, MD Hospital Carlos Haya, Málaga. Spain
PRS Account Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP