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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Erlotinib
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rash, Grade <2<br>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. | Drug: Erlotinib<br>* 100 mg, PO, once per day<br>* Other names: Tarceva;Drug: Gemcitabine<br>* 1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles<br>|
| Experimental: Rash, Grade ≥2<br>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. | Drug: Erlotinib<br>* 100 mg, PO, once per day<br>* Other names: Tarceva;Drug: Gemcitabine<br>* 1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Died During the Study |  | Enrollment through Cycle 24 (4-week cycles), up to 24 months. | 
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Died at 6 Months |  | Enrollment through Cycle 6 (4-week cycles), up to 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. | Enrollment through Cycle 6 (4-week cycles), up to 6 months. | 
| Number of Participants Who Died During the Study By Rash Grade |  | Enrollment through Cycle 24 (4-week cycles), up to 24 months. | 
| 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. | 
| 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. | 
| 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 | 
| 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. | 
| 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. |