NCT00642733

Brief Summary

This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8 weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_4 pancreatic-cancer

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_4 pancreatic-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

March 19, 2008

Last Update Submit

August 22, 2016

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival; time to progression

    6 months

Secondary Outcomes (2)

  • Duration of response; disease-free survival

    Event driven

  • AEs, lab parameters

    Throughout study

Study Arms (1)

1

EXPERIMENTAL
Drug: erlotinib [Tarceva]Drug: gemcitabine

Interventions

erlotinib [Tarceva]DRUG

100mg po daily

1
gemcitabineDRUG

1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, \>=18 years of age;
  • pancreatic cancer, surgically unresectable or with metastases;
  • no previous chemotherapy (except concomitant with radiotherapy);
  • ECOG 0-2.

You may not qualify if:

  • pancreatic cancer without histologic or cytologic confirmation;
  • surgical resection possible;
  • previous chemotherapy not concomitant with radiotherapy;
  • ECOG 3-4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Morelia, 58070, Mexico

Location

Unknown Facility

Tijuana, 22320, Mexico

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib HydrochlorideGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 25, 2008

Study Start

August 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

ME(2)