Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Gemcitabine

Erlotinib Hydrochloride

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.

Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.

Erlotinib

Participants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m\^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.

Clinical Trials

This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.

A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.

The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 ("no/not at all") to 4 ("very much") where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 ("very poor") to 7 ("excellent") where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available.

The percentage of participants who died from any cause was reported to the nearest integer.

OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months.

Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer.

Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months.

Hoffmann-La Roche

Analysis Population Description: Safety Population.

Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m\^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.

Erlotinib + Gemcitabine

Age, Continuous

Sex: Female, Male

Safety Population: All participants who received at least one dose of erlotinib.

Medical Communications

Percentage of Participants With Adverse Events (AEs)

Q1: Trouble in strenuous activities (n=256)

Q2: Trouble with long walk (n=259)

Q3: Trouble with short walk (n=258)

Q4: Need to say in bed or chair (n=255)

Q5: Need help in daily activities (n=259)

Q6: Limited in doing work/daily activities (n=257)

Q7: Limited in pursuing hobbies (n=255)

Q8: Short of breath (n=258)

Q9: Pain (n=257)

Q10: Need to rest (n=255)

Q11: Trouble sleeping (n=257)

Q12: Felt weak (n=255)

Q13: Lacked appetite (n=257)

Q14: Felt nauseated (n=257)

Q15: Vomited (n=259)

Q16: Constipated (n=259)

Q17: Diarrhea (n=259)

Q18: Tired (n=255)

Q19: Pain interference with daily activity (n=256)

Q20: Difficulty concentrating (n=257)

Q21: Felt tense (n=256)

Q22: Worried (n=253)

Q23: Felt irritable (n=258)

Q24: Felt depressed (n=258)

Q25: Difficulty remembering things (n=257)

Q26: Interference with family life (n=257)

Q27: Interference with social activities (n=257)

Q28: Financial difficulties (n=258)

Q29: Overall health (n=255)

Q30: Overall quality of life (n=255)

Safety Population. The "Number of Participants Analyzed" reflects the total number of participants who contributed to the endpoint. The number of responses for each questionnaire item combined across all assessments (n) is shown in the table.

European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores

Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint.

Percentage of Participants Who Died

Overall Survival (OS)

Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)

Progression-Free Survival (PFS) According to RECIST

Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 milligrams (mg) orally (PO) once daily. Gemcitabine was administered as 1000 milligrams per meter-squared (mg/m\^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.

Overall Study

Spots Global Cancer Trial Database for A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial