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

Roche

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Erlotinib; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00461708

ML20296

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Rash, Grade <2

Experimental group

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.

Treatment:

Drug: Erlotinib

Drug: Gemcitabine

Rash, Grade ≥2

Experimental group

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.

Treatment:

Drug: Erlotinib

Drug: Gemcitabine