Phase 2
Completed N=467
A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT00652366 ↗Enrolled (actual)
467
Serious AEs
36.2%
Results posted
Feb 2015
Primary outcomePrimary: Percentage of Participants Who Died Assessed From Point of Randomization — 81.3; 85.7 percentage of participants
Summary
This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. 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 Percentage of Participants Who Died Assessed From Point of Randomization |
81.3; 85.7 | — |
| PRIMARY OS Assessed From Point of Randomization |
8.4; 7.0 | 0.2026 |
| SECONDARY Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization |
90.7; 88.6 | — |
| SECONDARY PFS Assessed From Point of Randomization |
19.4; 15.3 | 0.6298 |
| SECONDARY Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST |
14.7; 8.6 | 0.2543 |
| SECONDARY Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST |
0.0; 1.4; 14.7; 7.1; 58.7; 72.9 | — |
| SECONDARY Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST |
62.7; 47.1 | 0.0603 |
| SECONDARY Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In |
84.9; 81.3; 85.7 | — |
| SECONDARY OS Assessed From Start of 4-Week Run-In |
7.9; 9.3; 8.0 | 0.2678 |
| SECONDARY Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In |
90.6; 90.7; 88.6 | — |
| SECONDARY PFS Assessed From the Start of 4-Week Run-In |
17.1; 23.4; 19.3 | 0.0217 sig |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- histologically or cytologically confirmed pancreatic cancer with measurable or non-measurable metastatic disease;
- ECOG performance status of 0-1.
Exclusion Criteria
- local, or locally advanced, pancreatic cancer;
- prior systemic treatment for metastatic pancreatic cancer;
- <=6 months since last adjuvant chemotherapy;
- other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer.
Data sourced from ClinicalTrials.gov (NCT00652366). 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.