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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier:
NCT01303029
First received: February 16, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: Gemcitabine+erlotinib
Drug: Gemcitabine+erlotinib+capecitabine
Phase 2

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 IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Response rate (RR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Percentage of rash in patients treated with erlotinib and progression free survival and overall survival and treatment relationship [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Gemcitabine+erlotinib
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 .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303029

Locations
Spain
Spanish Cooperative Group for Digestive Tumour Therapy
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
Hoffmann-La Roche
Investigators
Study Chair: Antonio Irigoyen, MD Hospital de Toledo, Spain
Study Chair: Manuel Benavides, MD Hospital Carlos Haya, Málaga. Spain
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier: NCT01303029     History of Changes
Other Study ID Numbers: TTD-10-01, 2010-022599-30
Study First Received: February 16, 2011
Last Updated: March 26, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):
Pancreatic cancer
gemcitabine
erlotinib
capecitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Fluorouracil
Erlotinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014