Trial · NCT00605722
A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.
NCT00605722, Phase 2, Completed, Hoffmann-La Roche; results first posted 2014-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer. Trials, record NCT00605722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00605722
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.
- NCT number
- NCT00605722
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Liver Cancer
- Interventions
- bevacizumab (Avastin), erlotinib (Tarceva)
- First posted
- 2008-01-31
- Last updated
- 2014-07-14
- Results first posted
- 2014-07-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression-free Survival (PFS) | Week 16 | Percentage of participants who were alive and without documented progressive disease 16 weeks after their first dose of study drug. Diagnosis of Progressive Disease was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Overall Response Rate (ORR) | Event driven (median follow-up 12 months) | ORR was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR). Analysis of tumor response was based on the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST), which was defined as the best response recorded from the start of trial treatment until disease progression/recurrence (or death), taking as reference for progressive disease (PD) the smallest measurements recorded since the treatment started. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD required at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Disease Control Rate (DCR) | Event driven (median follow-up 12 months) | Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 8 weeks by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. |
| Secondary | Time to Tumor Progression | Event driven (median follow-up 12 months) | Time to tumor progression was defined as the time period in months from the start of study drug treatment to disease progression. Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Progression-free Survival (PFS) | Event driven (median follow-up 12 months) | PFS was defined as the time period in months from the start of study drug treatment to the first of either progression or death. Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Overall Survival (OS) | Event driven (median follow-up 12 months) | OS was defined as the time period in months from the start of study drug treatment to death. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 107 Weeks | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Progression-free Survival (PFS) | Week 16 | Intent-to-treat population included all participants who received study drug. Participants who had neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Event driven (median follow-up 12 months) | Intent-to-treat population included all participants who received study drug. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Event driven (median follow-up 12 months) | Intent-to-treat population included all participants who received study drug. | Percentage of participants | NUMBER |
| SECONDARY | Time to Tumor Progression | Event driven (median follow-up 12 months) | Intent-to-treat population included all participants who received study drug. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Event driven (median follow-up 12 months) | Intent-to-treat population included all participants who received study drug. Participants were censored at the last follow-up visit. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Event driven (median follow-up 12 months) | Intent-to-treat population included all participants who received study drug. | months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 107 Weeks | Safety population included all participants who received at least one dose of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Progression-free Survival (PFS) | Bevacizumab + Erlotinib | 35.3 | 95% Confidence Interval 22.4 to 49.9 | percentage of participants | |
| Overall Response Rate (ORR) | Bevacizumab + Erlotinib | Complete Response | 0.0 | 95% Confidence Interval 0.0 to 7.0 | percentage of participants |
| Overall Response Rate (ORR) | Bevacizumab + Erlotinib | Partial Response | 5.9 | 95% Confidence Interval 1.2 to 16.2 | percentage of participants |
| Disease Control Rate (DCR) | Bevacizumab + Erlotinib | 52.9 | 95% Confidence Interval 38.5 to 67.1 | Percentage of participants | |
| Time to Tumor Progression | Bevacizumab + Erlotinib | 2.9 | 95% Confidence Interval 1.8 to 5.3 | Months | |
| Progression-free Survival (PFS) | Bevacizumab + Erlotinib | 2.9 | 95% Confidence Interval 1.8 to 4.8 | months | |
| Overall Survival (OS) | Bevacizumab + Erlotinib | 10.7 | 95% Confidence Interval 7.4 to NA | months | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Bevacizumab + Erlotinib | Serious Adverse Events | 19 | participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Bevacizumab + Erlotinib | Adverse Events | 51 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab + Erlotinib | 51 | |
| Overall Study | COMPLETED | Bevacizumab + Erlotinib | 0 | |
| Overall Study | NOT COMPLETED | Bevacizumab + Erlotinib | 51 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | Bevacizumab + Erlotinib | 36 | 51 | |
| other | Acne | Skin and subcutaneous tissue disorders | Bevacizumab + Erlotinib | 22 | 51 | |
| other | Palmer-Plantar erythrodysaesthesis syndrome | Skin and subcutaneous tissue disorders | Bevacizumab + Erlotinib | 11 | 51 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Bevacizumab + Erlotinib | 11 | 51 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Bevacizumab + Erlotinib | 7 | 51 | |
| other | Dry skin | Skin and subcutaneous tissue disorders | Bevacizumab + Erlotinib | 6 | 51 | |
| other | Diarrhea | Gastrointestinal disorders | Bevacizumab + Erlotinib | 26 | 51 | |
| other | Nausea | Gastrointestinal disorders | Bevacizumab + Erlotinib | 12 | 51 | |
| other | Vomiting | Gastrointestinal disorders | Bevacizumab + Erlotinib | 11 | 51 | |
| other | Constipation | Gastrointestinal disorders | Bevacizumab + Erlotinib | 8 | 51 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab + Erlotinib | ||
| Total, other adverse events | Bevacizumab + Erlotinib | 51 | 51 |
| Total, serious adverse events | Bevacizumab + Erlotinib | 19 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00605722
GET https://conductscience.org/api/trials/v1/NCT00605722/events?page=2