Adenomatous Polyp, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage I Colon Cancer, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer, Stage IIB Rectal Cancer, Stage IIC Colon Cancer, Stage IIC Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage I Rectal Cancer
Conditions
Brief summary
This randomized phase II trial is studying how well erlotinib hydrochloride works in treating patients with stage I-III colorectal cancer or adenoma. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Erlotinib hydrochloride may also stop tumors from growing or coming back
Detailed description
PRIMARY OBJECTIVES: I. To test the hypothesis that erlotinib (erlotinib hydrochloride) doses as low as 25 mg will decrease aberrant crypt foci (ACF) phosphorylated extracellular signal-regulated kinases (pERK) levels from baseline (pre) to post erlotinib treatment. SECONDARY OBJECTIVES: I. To test the hypothesis that additional epidermal growth factor (EGF) inducible biomarkers will decrease from baseline (pre) to post treatment with erlotinib 25 mg, 50 mg or 100 mg orally (PO) once daily (QD) therapy. II. To determine the mean decrease from baseline of the ACF: normal mucosa pERK ratio pre and post 8-30 days of erlotinib. III. To determine erlotinib concentration in plasma and colorectal tissue at 25 mg, 50 mg and 100 mg doses after 8-30 days of therapy. IV. To determine the incidence of rash, diarrhea and other side effects of low dose erlotinib. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD. ARM II: Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD. ARM III: Patients receive 25 mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD. In all arms, treatment continues for 8-30 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 to 9 weeks.
Interventions
DRUGerlotinib hydrochloride
Given PO
OTHERplacebo
Given PO
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with one or more of the following criteria will be eligible to participate: * History of Stage I-III colorectal cancer, not treated in the past 6 months with no anticipated treatment in the next 3 months * Adenoma ≥ 1 cm in size * 3 or more adenomas (of any size) removed at one colonoscopy within past 6 years * Sessile serrated adenoma ≥ 5 mm in size * Adenoma (of any size) with villous features (villous, tubulovillous) * Adenoma (of any size) with high grade dysplasia * Participants are eligible for randomization into the treatment phase of the trial if they are found to have ≥ 4 ACFs at either baseline colonoscopy or baseline flexible sigmoidoscopy * Blood tests at screening which meet the following criteria: * WBC \> 3000/mm\^3 * Platelets \> 100,000/mm\^3 * Hemoglobin \> 10g/dl * Plasma creatinine of \< 1.6mg/dl * Total bilirubin \< 1.5 x the upper limit of normal * Serum ALT \< 1.5 x the upper limit of normal * Serum AST \< 1.5 x the upper limit of normal * ECOG performance status 0-1 * Women of child-bearing potential and men taking study drug must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * Ability to understand, as well as sign the written informed consent document * If a woman is of child-bearing potential, she must have a negative pregnancy test prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Exclusion criteria
* History of Inflammatory Bowel Disease (IBD) * History of interstitial lung disease or chronic lung disease * Smoking within the past 3 months * Increased bleeding risk from rectal biopsy (Patients receiving aspirin or plavix can be enrolled) * Patients receiving warfarin or coumadin * Uncontrollable diarrhea of any cause * Patients, including rectal cancer patients, that have received prior radiation to the rectum or pelvis * Participants taking a known significant CYP 3A4 inducer or inhibitor; known significant inducers/inhibitors include: amprenavir, aprepitant, atazanavir, carbamazepine, clarithromycin, conivaptan, diltiazem, darunavir/ritonavir, dronedarone, erythromycin, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, phenytoin, posaconazole, rifampin, ritonavir, St. John's wort, saquinavir, telithromycin, tipranavir/ritonavir, verapamil, voriconazole * Women who are pregnant or breast-feeding * Active keratoconjunctivitis, or corneal surgery in the past three weeks * Any medical or psychosocial condition that could jeopardize the subject's participation in and compliance to the study * Participants who are taking any other investigational pharmaceutical agents * Previous history of sensitivity to erlotinib, Iressa, or Erbitux, such as a rash that is uncontrollable by topical steroids and/or antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ACF pERK Levels | From baseline to post-treatment (up to 30 days) | Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in EGF-inducible Markers - Total EGFR in Normal Mucosa | From baseline to post-treatment (up to 30 days) | Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported. |
| Change in EGF-inducible Markers - pEGFR in ACF | From baseline to post-treatment (up to 30 days) | pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported. |
| Change in EGF-inducible Markers - Total EGFR in ACF | From baseline to post-treatment (up to 30 days) | Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported. |
| ACF: Normal Mucosa pERK Ratio | Up to day 30 | Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons. |
| Plasma Erlotinib Concentration (ng/mL) | Up to day 30 | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). |
| Change in EGF-inducible Markers - pEGFR in Normal Mucosa | From baseline to post-treatment (up to 30 days) | pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported. |
| Normal Mucosa Erlotinib Concentration (ng/mg) | Up to day 30 | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). |
| Normal Mucosa OSI-420 Concentration (ng/mg) | Up to day 30 | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). |
| Number of Participants Reported at Least 1 Side Effect During the Study | Up to 9 weeks | Described for each arm using frequencies. The onset of adverse events is between randomization date and off-study date. |
| Number of Participants Reported at Least 1 Rash Side Effect During the Study | Up to 9 weeks | Described for each arm using frequencies. |
| Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study | Up to 9 weeks | Described for each arm using frequencies. |
| Plasma OSI-420 Concentration (ng/mL) | Up to day 30 | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (25 mg) Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies | 15 |
| Arm II (50 mg) Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies | 15 |
| Arm III (100 mg) Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.
erlotinib hydrochloride: Given PO
placebo: Given PO
laboratory biomarker analysis: Correlative studies | 15 |
| Total | 45 |
Baseline characteristics
| Characteristic | Arm I (25 mg) | Arm II (50 mg) | Arm III (100 mg) | Total |
|---|---|---|---|---|
| Age, Continuous | 63.67 years STANDARD_DEVIATION 4.43 | 62.47 years STANDARD_DEVIATION 6.03 | 60.67 years STANDARD_DEVIATION 7.42 | 62.27 years STANDARD_DEVIATION 6.08 |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 10 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 15 | 13 / 15 | 13 / 15 |
| serious Total, serious adverse events | 1 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in ACF pERK Levels
Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.
Time frame: From baseline to post-treatment (up to 30 days)
Population: Change in ACF pERK levels not reported as the assay did not demonstrate signaling
Secondary
ACF: Normal Mucosa pERK Ratio
Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons.
Time frame: Up to day 30
Population: ACF: pERK ratio not reported as the assay did not demonstrate signaling in ACF pERK levels
Secondary
Change in EGF-inducible Markers - pEGFR in ACF
pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Time frame: From baseline to post-treatment (up to 30 days)
Population: Outcome measure data is reported based on the evaluable samples collected and available results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arm I (25 mg) | Change in EGF-inducible Markers - pEGFR in ACF | 1.19 expression level |
| Arm II (50 mg) | Change in EGF-inducible Markers - pEGFR in ACF | 1.93 expression level |
| Arm III (100 mg) | Change in EGF-inducible Markers - pEGFR in ACF | 1.40 expression level |
Comparison: A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.651General Linear Model
Comparison: A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.03General Linear Model
Comparison: A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.261General Linear Model
Secondary
Change in EGF-inducible Markers - pEGFR in Normal Mucosa
pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Time frame: From baseline to post-treatment (up to 30 days)
Population: Outcome measure data is reported based on the evaluable samples collected and available results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arm I (25 mg) | Change in EGF-inducible Markers - pEGFR in Normal Mucosa | 0.84 expression level |
| Arm II (50 mg) | Change in EGF-inducible Markers - pEGFR in Normal Mucosa | 1.65 expression level |
| Arm III (100 mg) | Change in EGF-inducible Markers - pEGFR in Normal Mucosa | 0.97 expression level |
Comparison: A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.762General Linear Model
Comparison: A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.125General Linear Model
Comparison: A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.855General Linear Model
Secondary
Change in EGF-inducible Markers - Total EGFR in ACF
Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Time frame: From baseline to post-treatment (up to 30 days)
Population: Outcome measure data is reported based on the evaluable samples collected and available results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arm I (25 mg) | Change in EGF-inducible Markers - Total EGFR in ACF | 1.33 expression level |
| Arm II (50 mg) | Change in EGF-inducible Markers - Total EGFR in ACF | 2.22 expression level |
| Arm III (100 mg) | Change in EGF-inducible Markers - Total EGFR in ACF | 1.94 expression level |
Comparison: A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.654General Linear Model
Comparison: A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.03General Linear Model
Comparison: A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.083General Linear Model
Secondary
Change in EGF-inducible Markers - Total EGFR in Normal Mucosa
Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Time frame: From baseline to post-treatment (up to 30 days)
Population: Outcome measure data is reported based on the evaluable samples collected and available results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arm I (25 mg) | Change in EGF-inducible Markers - Total EGFR in Normal Mucosa | 2.02 expression level |
| Arm II (50 mg) | Change in EGF-inducible Markers - Total EGFR in Normal Mucosa | 1.91 expression level |
| Arm III (100 mg) | Change in EGF-inducible Markers - Total EGFR in Normal Mucosa | 1.23 expression level |
Comparison: A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.369General Linear Model
Comparison: A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.085General Linear Model
Comparison: A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.p-value: 0.233General Linear Model
Secondary
Normal Mucosa Erlotinib Concentration (ng/mg)
Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Time frame: Up to day 30
Population: Outcome measure data is reported based on the evaluable samples collected and available results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (25 mg) | Normal Mucosa Erlotinib Concentration (ng/mg) | 0.36 ng/mg | Standard Deviation 0.18 |
| Arm II (50 mg) | Normal Mucosa Erlotinib Concentration (ng/mg) | 1.38 ng/mg | Standard Deviation 1.23 |
| Arm III (100 mg) | Normal Mucosa Erlotinib Concentration (ng/mg) | 3.25 ng/mg | Standard Deviation 4.62 |
Secondary
Normal Mucosa OSI-420 Concentration (ng/mg)
Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Time frame: Up to day 30
Population: Outcome measure data is reported based on the evaluable samples collected and available results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (25 mg) | Normal Mucosa OSI-420 Concentration (ng/mg) | 0.04 ng/mg | Standard Deviation 0.01 |
| Arm II (50 mg) | Normal Mucosa OSI-420 Concentration (ng/mg) | 0.17 ng/mg | Standard Deviation 0.15 |
| Arm III (100 mg) | Normal Mucosa OSI-420 Concentration (ng/mg) | 0.29 ng/mg | Standard Deviation 0.24 |
Secondary
Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study
Described for each arm using frequencies.
Time frame: Up to 9 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (25 mg) | Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study | At least 1 diarrhea AE reported | 4 participants |
| Arm I (25 mg) | Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study | No diarrhea AE reported | 11 participants |
| Arm II (50 mg) | Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study | At least 1 diarrhea AE reported | 4 participants |
| Arm II (50 mg) | Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study | No diarrhea AE reported | 11 participants |
| Arm III (100 mg) | Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study | At least 1 diarrhea AE reported | 5 participants |
| Arm III (100 mg) | Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study | No diarrhea AE reported | 10 participants |
Secondary
Number of Participants Reported at Least 1 Rash Side Effect During the Study
Described for each arm using frequencies.
Time frame: Up to 9 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (25 mg) | Number of Participants Reported at Least 1 Rash Side Effect During the Study | At least 1 rash AE reported | 5 participants |
| Arm I (25 mg) | Number of Participants Reported at Least 1 Rash Side Effect During the Study | No rash AE reported | 10 participants |
| Arm II (50 mg) | Number of Participants Reported at Least 1 Rash Side Effect During the Study | At least 1 rash AE reported | 6 participants |
| Arm II (50 mg) | Number of Participants Reported at Least 1 Rash Side Effect During the Study | No rash AE reported | 9 participants |
| Arm III (100 mg) | Number of Participants Reported at Least 1 Rash Side Effect During the Study | At least 1 rash AE reported | 12 participants |
| Arm III (100 mg) | Number of Participants Reported at Least 1 Rash Side Effect During the Study | No rash AE reported | 3 participants |
Secondary
Number of Participants Reported at Least 1 Side Effect During the Study
Described for each arm using frequencies. The onset of adverse events is between randomization date and off-study date.
Time frame: Up to 9 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (25 mg) | Number of Participants Reported at Least 1 Side Effect During the Study | At least 1 adverse event reported | 12 participants |
| Arm I (25 mg) | Number of Participants Reported at Least 1 Side Effect During the Study | No adverse event reported | 3 participants |
| Arm II (50 mg) | Number of Participants Reported at Least 1 Side Effect During the Study | At least 1 adverse event reported | 13 participants |
| Arm II (50 mg) | Number of Participants Reported at Least 1 Side Effect During the Study | No adverse event reported | 2 participants |
| Arm III (100 mg) | Number of Participants Reported at Least 1 Side Effect During the Study | At least 1 adverse event reported | 13 participants |
| Arm III (100 mg) | Number of Participants Reported at Least 1 Side Effect During the Study | No adverse event reported | 2 participants |
Secondary
Plasma Erlotinib Concentration (ng/mL)
Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Time frame: Up to day 30
Population: Outcome measure data is reported based on the evaluable samples collected and available results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (25 mg) | Plasma Erlotinib Concentration (ng/mL) | 232.29 ng/mL | Standard Deviation 160.6 |
| Arm II (50 mg) | Plasma Erlotinib Concentration (ng/mL) | 486.56 ng/mL | Standard Deviation 211.8 |
| Arm III (100 mg) | Plasma Erlotinib Concentration (ng/mL) | 1280.84 ng/mL | Standard Deviation 788.3 |
Secondary
Plasma OSI-420 Concentration (ng/mL)
Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Time frame: Up to day 30
Population: Outcome measure data is reported based on the evaluable samples collected and available results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (25 mg) | Plasma OSI-420 Concentration (ng/mL) | 17.77 ng/mL | Standard Deviation 12.3 |
| Arm II (50 mg) | Plasma OSI-420 Concentration (ng/mL) | 33.87 ng/mL | Standard Deviation 14.1 |
| Arm III (100 mg) | Plasma OSI-420 Concentration (ng/mL) | 117.98 ng/mL | Standard Deviation 84.5 |