Phase 2
Completed N=153
A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
Source: ClinicalTrials.gov NCT00461708 ↗Enrolled (actual)
153
Serious AEs
47.1%
Results posted
Oct 2015
Primary outcomePrimary: Number of Participants Who Died During the Study — 102; 27 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Died During the Study |
102; 27 | — |
| PRIMARY Overall Survival (OS) During the Study |
4.468; 10.546 | — |
| SECONDARY Number of Participants Who Died at 6 Months |
69; 8 | — |
| SECONDARY OS At 6 Months |
4.468; NA | — |
| SECONDARY Number of Participants Who Died During the Study By Rash Grade |
65; 37; 27 | — |
| SECONDARY OS By Rash Grade |
3.318; 6.571; 10.546 | — |
| SECONDARY Number of Participants With Disease Progression or Death |
110; 33 | — |
| SECONDARY PFS |
2.497; 6.439 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST |
7.0; 21.1 | <0.05 sig |
| SECONDARY Percentage of Participants With Disease Control According to RECIST |
42.6; 84.2 | <0.05 sig |
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.
Data sourced from ClinicalTrials.gov (NCT00461708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.