A Phase 3 interventional study of Erlotinib and Gemcitabine in Pancreatic Cancer, sponsored by Hoffmann-La Roche. Completed at 11 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-24.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 80 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
Drug: Erlotinib · Drug: Gemcitabine
Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.
Also known as: Tarceva
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.
Percentage of Participants With Adverse Events (AEs)
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.
Time frame: Up to approximately 40 months (assessed continuously during treatment)
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
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.
Time frame: Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)
Percentage of Participants Who Died
The percentage of participants who died from any cause was reported to the nearest integer.
Time frame: Up to approximately 40 months (assessed continuously through end of study)
Overall Survival (OS)
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.
Time frame: Up to approximately 40 months (assessed continuously through end of study)
Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)
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.
Time frame: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
Progression-Free Survival (PFS) According to RECIST
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.
Time frame: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)
| Milestone | Erlotinib + Gemcitabine |
|---|---|
| Started | 80 |
| Completed | 0 |
| Not completed | 80 |
| Withdrew: Progressive disease | 40 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Study drug-related adverse event | 1 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Death | 8 |
| Withdrew: Other | 22 |
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.
| percentage of participants | Erlotinib + Gemcitabine |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | 78.8 |
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.
| units on a scale | Erlotinib + Gemcitabine |
|---|---|
| Q1: Trouble in strenuous activities (n=256) | 1.96 ± 0.758 |
| Q2: Trouble with long walk (n=259) | 2.03 ± 0.802 |
| Q3: Trouble with short walk (n=258) | 1.50 ± 0.696 |
| Q4: Need to say in bed or chair (n=255) | 1.87 ± 0.699 |
| Q5: Need help in daily activities (n=259) | 1.21 ± 0.501 |
| Q6: Limited in doing work/daily activities (n=257) | 1.82 ± 0.803 |
| Q7: Limited in pursuing hobbies (n=255) | 1.73 ± 0.798 |
| Q8: Short of breath (n=258) | 1.38 ± 0.608 |
| Q9: Pain (n=257) | 1.88 ± 0.771 |
| Q10: Need to rest (n=255) | 2.05 ± 0.697 |
| Q11: Trouble sleeping (n=257) | 1.74 ± 0.699 |
| Q12: Felt weak (n=255) | 2.05 ± 0.774 |
| Q13: Lacked appetite (n=257) | 1.70 ± 0.730 |
| Q14: Felt nauseated (n=257) | 1.48 ± 0.679 |
| Q15: Vomited (n=259) | 1.10 ± 0.414 |
| Q16: Constipated (n=259) | 1.51 ± 0.723 |
| Q17: Diarrhea (n=259) | 1.27 ± 0.496 |
| Q18: Tired (n=255) | 2.07 ± 0.689 |
| Q19: Pain interference with daily activity (n=256) | 1.69 ± 0.814 |
| Q20: Difficulty concentrating (n=257) | 1.49 ± 0.638 |
| Q21: Felt tense (n=256) | 1.97 ± 0.716 |
| Q22: Worried (n=253) | 2.10 ± 0.773 |
| Q23: Felt irritable (n=258) | 1.75 ± 0.707 |
| Q24: Felt depressed (n=258) | 1.67 ± 0.658 |
| Q25: Difficulty remembering things (n=257) | 1.44 ± 0.543 |
| Q26: Interference with family life (n=257) | 1.59 ± 0.680 |
| Q27: Interference with social activities (n=257) | 1.62 ± 0.772 |
| Q28: Financial difficulties (n=258) | 1.32 ± 0.655 |
| Q29: Overall health (n=255) | 4.44 ± 1.314 |
| Q30: Overall quality of life (n=255) | 4.38 ± 1.346 |
The percentage of participants who died from any cause was reported to the nearest integer.
| percentage of participants | Erlotinib + Gemcitabine |
|---|---|
| Percentage of Participants Who Died | 73 |
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.
| months | Erlotinib + Gemcitabine |
|---|---|
| Overall Survival (OS) | 7.49 (5.42 to 9.04) |
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.
| percentage of participants | Erlotinib + Gemcitabine |
|---|---|
| Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST) | 88 |
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.
| months | Erlotinib + Gemcitabine |
|---|---|
| Progression-Free Survival (PFS) According to RECIST | 4.864 (3.484 to 5.850) |
Collected over Up to approximately 40 months (assessed continuously during treatment). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib + Gemcitabine | — | 35/80 (43.8%) | 44/80 (55%) |
| Event | Erlotinib + Gemcitabine |
|---|---|
| Disease progressionGeneral disorders | 6/80 |
| Abdominal painGastrointestinal disorders | 3/80 |
| JaundiceHepatobiliary disorders | 3/80 |
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/80 |
| Cardiac arrestCardiac disorders | 2/80 |
| Pancreatic carcinomaGastrointestinal disorders | 2/80 |
| General physical health deteriorationGeneral disorders | 2/80 |
| Hepatic failureHepatobiliary disorders | 2/80 |
| PneumoniaInfections and infestations | 2/80 |
| Cerebrovascular accidentNervous system disorders | 2/80 |
| Event | Erlotinib + Gemcitabine |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 21/80 |
| ThrombocytopeniaBlood and lymphatic system disorders | 18/80 |
| LeukopeniaBlood and lymphatic system disorders | 14/80 |
| PyrexiaGeneral disorders | 12/80 |
| NeutropeniaBlood and lymphatic system disorders | 9/80 |
| ConstipationGastrointestinal disorders | 5/80 |
| HepatotoxicityHepatobiliary disorders | 5/80 |
| Alanine aminotransferase increasedInvestigations | 5/80 |
| Aspartate aminotransferase increasedInvestigations | 5/80 |
| Abdominal painGastrointestinal disorders | 4/80 |
Safety Population: All participants who received at least one dose of erlotinib.
| Age, Continuous(years) | Erlotinib + Gemcitabine |
|---|---|
| Mean | 62.45 ± 10.299 |
| Sex: Female, Male(Participants) | Erlotinib + Gemcitabine |
|---|---|
| Female | 32 |
| Male | 48 |
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