Back to resultsA Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Erlotinib
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Rash, Grade <2
Rash, Grade ≥2
Arm Description
Participants with a rash graded less than (<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
Outcomes
Primary Outcome Measures
Number of Participants Who Died During the Study
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.
Secondary Outcome Measures
Number of Participants Who Died at 6 Months
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.
Number of Participants Who Died During the Study By Rash Grade
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00461708
Brief Title
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
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rash, Grade <2
Arm Type
Experimental
Arm Description
Participants with a rash graded less than (<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
Arm Title
Rash, Grade ≥2
Arm Type
Experimental
Arm Description
Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
100 mg, PO, once per day
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
Primary Outcome Measure Information:
Title
Number of Participants Who Died During the Study
Time Frame
Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Title
Overall Survival (OS) During the Study
Description
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.
Time Frame
Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Secondary Outcome Measure Information:
Title
Number of Participants Who Died at 6 Months
Time Frame
Enrollment through Cycle 6 (4-week cycles), up to 6 months.
Title
OS At 6 Months
Description
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.
Time Frame
Enrollment through Cycle 6 (4-week cycles), up to 6 months.
Title
Number of Participants Who Died During the Study By Rash Grade
Time Frame
Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Title
OS By Rash Grade
Description
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.
Time Frame
Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Title
Number of Participants With Disease Progression or Death
Description
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.
Time Frame
Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
Title
PFS
Description
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.
Time Frame
Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months
Title
Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST
Description
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.
Time Frame
Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
Title
Percentage of Participants With Disease Control According to RECIST
Description
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.
Time Frame
Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Alcoy
State/Province
Alicante
ZIP/Postal Code
03804
Country
Spain
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
City
Sabadell, Barcelona
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
City
La Coruna
State/Province
La Coruña
ZIP/Postal Code
15006
Country
Spain
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
City
Barcelona
ZIP/Postal Code
08227
Country
Spain
City
Barcelona
ZIP/Postal Code
08906
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
Granada
ZIP/Postal Code
18014
Country
Spain
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
City
Jaen
ZIP/Postal Code
23007
Country
Spain
City
Lerida
ZIP/Postal Code
25198
Country
Spain
City
Lugo
ZIP/Postal Code
27004
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Murcia
ZIP/Postal Code
30008
Country
Spain
City
Murcia
ZIP/Postal Code
30120
Country
Spain
City
Navarra
ZIP/Postal Code
31008
Country
Spain
City
Pontevedra
ZIP/Postal Code
36002
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Valencia
ZIP/Postal Code
41014
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
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