Clinical trial NCT00461708: A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
Official title: An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-04-18
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* locally advanced and/or metastatic pancreatic cancer (stage III or IV);
* Karnofsky performance Status of \>=60%.

Exclusion Criteria:

* local(stage IA to IIB) pancreatic cancer;
* \<=6 months since last adjuvant chemotherapy;
* previous systemic therapy for metastatic pancreatic cancer;
* other primary tumor within last 5 years (except for adequately treated cancer in situ of cervix, or basal cell skin cancer);
* clinically significant cardiovascular disease.

Primary outcomes:
measure: Number of Participants Who Died During the Study
timeFrame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
measure: Overall Survival (OS) During the Study
timeFrame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Secondary outcomes:
measure: Number of Participants Who Died at 6 Months
timeFrame: Enrollment through Cycle 6 (4-week cycles), up to 6 months.
measure: OS At 6 Months
timeFrame: Enrollment through Cycle 6 (4-week cycles), up to 6 months.
measure: Number of Participants Who Died During the Study By Rash Grade
timeFrame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
measure: OS By Rash Grade
timeFrame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
measure: Number of Participants With Disease Progression or Death
timeFrame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
measure: PFS
timeFrame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months
measure: Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST
timeFrame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
measure: Percentage of Participants With Disease Control According to RECIST
timeFrame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
Other outcomes:
Locations:
city: Alcoy
country: Spain
state: Alicante
city: Elche
country: Spain
state: Alicante
city: Manresa
country: Spain
state: Barcelona
city: Sabadell, Barcelona
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: La Coruna
country: Spain
state: La Coruña
city: Alcorcon
country: Spain
state: Madrid
city: Sagunto
country: Spain
state: Valencia
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: Guadalajara
country: Spain
city: Jaen
country: Spain
city: Lerida
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Murcia
country: Spain
city: Navarra
country: Spain
city: Pontevedra
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: