A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Erlotinib, escalating dose; Drug: Gemcitabine; Drug: Erlotinib, standard dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652366

2007-003751-37

BO21128

Details and patient eligibility

About

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.

Enrollment: 467 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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467 participants in 2 patient groups

Gemcitabine, Erlotinib Standard Dose

Active Comparator group

Description:

Participants received erlotinib, 100 milligrams (mg), orally (PO), once daily until disease progression or unacceptable toxicity. Participants also received gemcitabine, 1000 mg per (/) square meter (m\^2), intravenously (IV), on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.

Treatment:

Drug: Gemcitabine

Drug: Erlotinib, standard dose

Gemcitabine, Erlotinib Escalating Dose

Experimental group

Description:

Participants received erlotinib, beginning at 150 mg/day, PO, once daily, and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal. Participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.

Treatment:

Drug: Gemcitabine

Drug: Erlotinib, escalating dose