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

Metastatic Adenocarcinoma of the Pancreas Clinical Trial

— XELTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873353
• Other study ID #: ML21154
• Secondary ID: 2007-003206-96
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2009
• Last updated: August 17, 2010
• Start date: March 2008
• Est. completion date: August 2010

Study information

• Verified date: August 2010
• Source: Grupo Gallego de Investigaciones Oncologicas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Adenocarcinoma of the Pancreas
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Arquitecto Marcide	Ferrol	La Coruña
Spain	Centro Oncológico de Galicia	La Coruña
Spain	Complejo Hospitalario Universitario de La Coruña	La Coruña
Spain	Complejo Hospitalario Xeral Calde	Lugo
Spain	Complejo Hospitalario de Orense	Orense
Spain	Complejo Hospitalario Xeral Cies	Vigo
Spain	Hospital do Meixoeiro	Vigo
Spain	Hospital POVISA	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Gallego de Investigaciones Oncologicas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate following RECIST criteria		within study period
Secondary	Overall survival		within study period
Secondary	6 months survival rate		within first 6 months after study inclusion
Secondary	Progression Free Survival (PFS)		Time from study inclusion to disease progression
Secondary	Time to treatment failure (TTF)		Time from study inclusion to treatment failure
Secondary	To determine the index of clinical benefit		at the end of the study
Secondary	To determine the safety and tolerability of erlotinib and capecitabine when administered together		Within study period