Trial to Evaluate the Efficacy and Safety of Tarceva and Capecitabine in Advanced Pancreatic Cancer Patients (XELTA)

An Open Non-randomized Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Tarceva in Combination With Capecitabine in Patients With Advanced Pancreatic Cancer

The purpose of this study is to determine efficacy of the treatment with erlotinib in combination with capecitabine in patients with advanced pancreatic cancer.

Study Overview

• Status: Completed
• Conditions: Metastatic Adenocarcinoma of the Pancreas
• Intervention / Treatment: Drug: capecitabine + erlotinib

Detailed Description

This efficacy will be determined by objective response rate following RECIST criteria.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • La Coruña, Spain, 15009
    • Centro Oncologico de Galicia
  • La Coruña, Spain, 15006
    • Complejo Hospitalario Universitario de la Coruña
  • Lugo, Spain, 27004
    • Complejo Hospitalario Xeral Calde
  • Orense, Spain, 32005
    • Complejo Hospitalario de Orense
  • Vigo, Spain, 36200
    • Hospital Do Meixoeiro
  • Vigo, Spain, 36204
    • Complejo Hospitalario Xeral Cies
  • Vigo, Spain, 36211
    • Hospital Povisa
  • La Coruña
    • Ferrol, La Coruña, Spain, 15405
      • Hospital Arquitecto Marcide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent
2. Informed consent signed by the patient
3. Age > 18 years old
4. Able to fulfill all criteria from the protocol
5. Performance status Karnofsky ≥ 60% (ECOG 0-2)
6. Life expectancy ≥ 12 weeks
7. Histologically or cytological (excluding endocrine pancreatic tumour), with metastatic (stage IV), following 6th edition of TNM classification
8. Measurable disease following RECIST criteria

9. Adequate bone marrow function as determined by:

   • Absolute Neutrophil account (ANC) ≥ 1,5 x 109/L
   • Platelets: ≥ 100 x 109/L
   • Hemoglobin: ≥ 9 g/dL.

10. Adequate liver function, as determined by:

    • Serum bilirubin (total): ≤ 1,5 x LSN
    • AST, ALT ≤ 2,5 x LSN in patients without liver metastasis. In patients with liver metastasis ≤ 5 x LSN

11. Adequate renal function, as determined by:

    • Clearance creatinine > 60.0 ml/min
12. Men or women potentially fertile (including postmenopausal women amenorrheic at least 24 months before the study) should use adequate contraceptive methods (oral contraceptives, intrauterine disposal, barrier methods together with spermicide or surgery sterilization)

Exclusion Criteria:

1. Local pancreatic cancer (stage IA-IIB) or locally advance cancer (stage III), following the TNM 6th edition classification. Patients with metastatic disease that relapse after the initial diagnosis of local or advance disease could be included in this study.
2. Evidence of medullary compression, carcinomatosis meningitis or brain metastasis. In case of clinical suspicious of brain metastasis is mandatory to perform a brain TAC/MR 4 weeks prior inclusion.
3. Previous systemic treatment for metastasis pancreas cancer. Adjuvant chemotherapy is permitted ≥ 4 weeks prior de inclusion. All toxicities from the adjuvant treatment must been solve before the inclusion and should be confirmed the diseases progression (metastatic disease) alter adjuvant treatment
4. Primary tumours Developer 5 years previous to the inclusion, except in situ cérvix carcinoma or skin basocellular cancer properly treated

5. Non-controlled hypertension or cardiovascular disease clinically significant (active):

   • Cerebrovascular accident/ictus (≤ 6 weeks prior to inclusion)
   • Heart attack (≤ 6 months prior to inclusion)
   • Instable angina
   • Congestive cardiac insufficiency (grade II or superior following to New York Heart Association (NYHA)
   • Severe cardiac arrhythmia that require medication
6. Significant ophthalmology 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 latency period. Negative pregnancy test needed 7 days prior to initiation drug study
10. Actual or 30 days previous to study treatment with other investigational drug or participation in other trial
11. Previous treatment with Capecitabine or EGFR inhibitor.
12. Any other disease, metabolic disease
13. Known hypersensibility to any study drug or any of their component, or to 5-fluorouracile

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unique arm; 6 cycles (3 weeks each one) of : capecitabine 1000mg/m2, bid, oral. Days: 1-14 every three weeks; erlotinib (Tarceva®) 150mg/day, oral. Days: every days	Drug: capecitabine + erlotinib; 6 cycles (3 weeks each one) of : capecitabine 1000mg/m2, bid, oral. Days: 1-14 every three weeks; erlotinib (Tarceva®) 150mg/day, oral. Days: every days; Other Names: capecitabine (Xeloda®)y erlotinib (Tarceva®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate following RECIST criteria	within study period

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	within study period
6 months survival rate	within first 6 months after study inclusion
Progression Free Survival (PFS)	Time from study inclusion to disease progression
Time to treatment failure (TTF)	Time from study inclusion to treatment failure
To determine the index of clinical benefit	at the end of the study
To determine the safety and tolerability of erlotinib and capecitabine when administered together	Within study period

Collaborators and Investigators

• Sponsor: Grupo Gallego de Investigaciones Oncologicas
• Investigators: Study Chair: Rafel López López, Coordinator, Grupo Gallego de Investigaciones Oncológicas

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: March 31, 2009
• First Submitted That Met QC Criteria: March 31, 2009
• First Posted (Estimate): April 1, 2009

Study Record Updates

• Last Update Posted (Estimate): August 18, 2010
• Last Update Submitted That Met QC Criteria: August 17, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Metastatic Adenocarcinoma of the Pancreas
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride; Capecitabine
• Other Study ID Numbers: ML21154; 2007-003206-96 (EudraCT Number)