A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461708
• Other study ID #: ML20296
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2007
• Last updated: September 14, 2015
• Start date: May 2007
• Est. completion date: November 2010

Study information

• Verified date: September 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Espanola del Medicamento (AEM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Erlotinib
100 mg, PO, once per day
• Gemcitabine
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Died During the Study		Enrollment through Cycle 24 (4-week cycles), up to 24 months.	No
Primary	Overall Survival (OS) During the Study	OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.	Enrollment through Cycle 24 (4-week cycles), up to 24 months.	No
Secondary	Number of Participants Who Died at 6 Months		Enrollment through Cycle 6 (4-week cycles), up to 6 months.	No
Secondary	OS At 6 Months	OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.	Enrollment through Cycle 6 (4-week cycles), up to 6 months.	No
Secondary	Number of Participants Who Died During the Study By Rash Grade		Enrollment through Cycle 24 (4-week cycles), up to 24 months.	No
Secondary	OS By Rash Grade	OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.	Enrollment through Cycle 24 (4-week cycles), up to 24 months.	No
Secondary	Number of Participants With Disease Progression or Death	Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.	Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.	No
Secondary	PFS	The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.	Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months	No
Secondary	Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST	As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.	Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.	No
Secondary	Percentage of Participants With Disease Control According to RECIST	Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.	Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.	No