A Phase 2 interventional study of Erlotinib and Gemcitabine in Pancreatic Cancer, sponsored by Hoffmann-La Roche. Completed at 29 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-15.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 153 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.
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Exclusion Criteria:
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.
Drug: Erlotinib · Drug: Gemcitabine
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.
Drug: Erlotinib · Drug: Gemcitabine
100 mg, PO, once per day
Also known as: Tarceva
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
Number of Participants Who Died During the Study
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Overall Survival (OS) During the Study
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Number of Participants Who Died at 6 Months
Time frame: Enrollment through Cycle 6 (4-week cycles), up to 6 months.
OS At 6 Months
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
Time frame: Enrollment through Cycle 6 (4-week cycles), up to 6 months.
Number of Participants Who Died During the Study By Rash Grade
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
OS By Rash Grade
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Number of Participants With Disease Progression or Death
Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
PFS
The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months
Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST
As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
Percentage of Participants With Disease Control According to RECIST
Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
| Milestone | Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2 | Erlotinib, Gemcitabine: Rash Grade Greater Than/Equal to (≥) 2 |
|---|---|---|
| Started | 115 | 38 |
| Completed | 0 | 0 |
| Not completed | 115 | 38 |
| Withdrew: Adverse event | 17 | 7 |
| Withdrew: Lack of efficacy | 68 | 20 |
| Withdrew: Physician decision | 10 | 4 |
| Withdrew: Withdrawal by subject | 8 | 2 |
| Withdrew: Other | 4 | 4 |
| Withdrew: Death | 8 | 1 |
| participants | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|
| Number of Participants Who Died During the Study | 102 | 27 |
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
| months | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|
| Overall Survival (OS) During the Study | 4.468 (3.618 to 5.318) | 10.546 (9.679 to 11.414) |
| participants | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|
| Number of Participants Who Died at 6 Months | 69 | 8 |
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
| months | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|
| OS At 6 Months | 4.468 (3.618 to 5.318) | NA (NA to NA) |
| participants | Erlotinib, Gemcitabine: Rash Grade 0 | Erlotinib, Gemcitabine: Rash Grade 1 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|---|
| Number of Participants Who Died During the Study By Rash Grade | 65 | 37 | 27 |
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
| months | Erlotinib, Gemcitabine: Rash Grade 0 | Erlotinib, Gemcitabine: Rash Grade 1 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|---|
| OS By Rash Grade | 3.318 (2.446 to 4.191) | 6.571 (5.139 to 8.003) | 10.546 (9.679 to 11.414) |
Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.
| participants | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|
| Number of Participants With Disease Progression or Death | 110 | 33 |
The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.
| months | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|
| PFS | 2.497 (2.130 to 2.864) | 6.439 (4.919 to 7.960) |
As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.
| percentage of participants | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|
| Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST | 7.0 | 21.1 |
Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.
| percentage of participants | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|
| Percentage of Participants With Disease Control According to RECIST | 42.6 | 84.2 |
Collected over Adverse events (AEs) were recorded at every study visit for up to a maximum of 24 treatment cycles.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib, Gemcitabine: Rash Grade < 2 | — | 58/115 (50.4%) | 115/115 (100%) |
| Erlotinib, Gemcitabine: Rash Grade ≥ 2 | — | 14/38 (36.8%) | 38/38 (100%) |
| Event | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|
| Obstruction, GIGastrointestinal disorders | 11/115 | 2/38 |
| Lung (pneumonia)Infections and infestations | 3/115 | 3/38 |
| FeverGeneral disorders | 4/115 | 2/38 |
| BloodInfections and infestations | 4/115 | 2/38 |
| CNS Cerebrovascular ischemiaNervous system disorders | 1/115 | 2/38 |
| Abdomen nosGastrointestinal disorders | 5/115 | 0/38 |
| FatigueGeneral disorders | 4/115 | 1/38 |
| Haemorrhage, GIGastrointestinal disorders | 3/115 | 1/38 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/115 | 1/38 |
| Left ventricular dysfunctionCardiac disorders | 0/115 | 1/38 |
| Event | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 |
|---|---|---|
| FatigueGeneral disorders | 89/115 | 31/38 |
| Abdomen nosMusculoskeletal and connective tissue disorders | 78/115 | 19/38 |
| AnorexiaMetabolism and nutrition disorders | 62/115 | 11/38 |
| DiarrheaGastrointestinal disorders | 55/115 | 15/38 |
| NeutropeniaBlood and lymphatic system disorders | 20/115 | 16/38 |
| NauseaGastrointestinal disorders | 43/115 | 12/38 |
| ConstipationGastrointestinal disorders | 38/115 | 12/38 |
| VomitingGastrointestinal disorders | 34/115 | 8/38 |
| FeverGeneral disorders | 18/115 | 11/38 |
| AnaemiaBlood and lymphatic system disorders | 32/115 | 11/38 |
Intent-to-treat (ITT) population: all participants included in the study.
| Age, Continuous(years) | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | Total |
|---|---|---|---|
| Mean | 63.6 ± 9.9 | 62.0 ± 10.6 | 63.2 ± 10.1 |
| Sex: Female, Male(Participants) | Erlotinib, Gemcitabine: Rash Grade < 2 | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | Total |
|---|---|---|---|
| Female | 61 | 10 | 71 |
| Male | 54 | 28 | 82 |
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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