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| ID | Type | Description | Link |
|---|---|---|---|
| UCI06-8-01 | |||
| N01CN35160 | U.S. NIH Grant/Contract | View source | |
| CDR0000614277 | Registry Identifier | PDQ (Physician Data Query) |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib Hydrochloride (25 mg) | Experimental | Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD. |
|
| Erlotinib Hydrochloride (50 mg) | Experimental | Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD. |
|
| Erlotinib Hydrochloride (100 mg) | Experimental | Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib hydrochloride | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to post-treatment (up to 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Participants with one or more of the following criteria will be eligible to participate:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Morgan | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Long Beach Healthcare System | Long Beach | California | 90822 | United States | ||
| Chao Family Comprehensive Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Arm II (50 mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| placebo | Other | Given PO |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| From baseline to post-treatment (up to 30 days) |
| 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. | From baseline to post-treatment (up to 30 days) |
| 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. | From baseline to post-treatment (up to 30 days) |
| 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. | From baseline to post-treatment (up to 30 days) |
| 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. | Up to day 30 |
| Plasma Erlotinib Concentration (ng/mL) | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). | Up to day 30 |
| Plasma OSI-420 Concentration (ng/mL) | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). | Up to day 30 |
| Normal Mucosa Erlotinib Concentration (ng/mg) | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). | Up to day 30 |
| Normal Mucosa OSI-420 Concentration (ng/mg) | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). | Up to day 30 |
| 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. | Up to 9 weeks |
| Number of Participants Reported at Least 1 Rash Side Effect During the Study | Described for each arm using frequencies. | Up to 9 weeks |
| Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study | Described for each arm using frequencies. | Up to 9 weeks |
| Orange |
| California |
| 92868 |
| United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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 |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Change in ACF pERK levels not reported as the assay did not demonstrate signaling | Posted | From baseline to post-treatment (up to 30 days) |
|
| |||||||||||||||||||||||||
| 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. | Outcome measure data is reported based on the evaluable samples collected and available results. | Posted | Geometric Mean | 95% Confidence Interval | expression level | From baseline to post-treatment (up to 30 days) |
| |||||||||||||||||||||||
| 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. | Outcome measure data is reported based on the evaluable samples collected and available results. | Posted | Geometric Mean | 95% Confidence Interval | expression level | From baseline to post-treatment (up to 30 days) |
| |||||||||||||||||||||||
| 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. | Outcome measure data is reported based on the evaluable samples collected and available results. | Posted | Geometric Mean | 95% Confidence Interval | expression level | From baseline to post-treatment (up to 30 days) |
| |||||||||||||||||||||||
| 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. | Outcome measure data is reported based on the evaluable samples collected and available results. | Posted | Geometric Mean | 95% Confidence Interval | expression level | From baseline to post-treatment (up to 30 days) |
| |||||||||||||||||||||||
| 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. | ACF: pERK ratio not reported as the assay did not demonstrate signaling in ACF pERK levels | Posted | Up to day 30 |
| ||||||||||||||||||||||||||
| Secondary | Plasma Erlotinib Concentration (ng/mL) | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). | Outcome measure data is reported based on the evaluable samples collected and available results. | Posted | Mean | Standard Deviation | ng/mL | Up to day 30 |
| |||||||||||||||||||||||
| Secondary | Plasma OSI-420 Concentration (ng/mL) | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). | Outcome measure data is reported based on the evaluable samples collected and available results. | Posted | Mean | Standard Deviation | ng/mL | Up to day 30 |
| |||||||||||||||||||||||
| Secondary | Normal Mucosa Erlotinib Concentration (ng/mg) | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). | Outcome measure data is reported based on the evaluable samples collected and available results. | Posted | Mean | Standard Deviation | ng/mg | Up to day 30 |
| |||||||||||||||||||||||
| Secondary | Normal Mucosa OSI-420 Concentration (ng/mg) | Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations). | Outcome measure data is reported based on the evaluable samples collected and available results. | Posted | Mean | Standard Deviation | ng/mg | Up to day 30 |
| |||||||||||||||||||||||
| 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. | Posted | Number | participants | Up to 9 weeks |
| |||||||||||||||||||||||||
| Secondary | Number of Participants Reported at Least 1 Rash Side Effect During the Study | Described for each arm using frequencies. | Posted | Number | participants | Up to 9 weeks |
|
| ||||||||||||||||||||||||
| Secondary | Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study | Described for each arm using frequencies. | Posted | Number | participants | Up to 9 weeks |
|
The onset date of adverse event is between the randomization date and the date of off-study, up to 95 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 15 | 12 | 15 | ||
| EG001 | 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 | 0 | 15 | 13 | 15 | ||
| EG002 | 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 | 0 | 15 | 13 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHEST PAIN | Cardiac disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 80% DIMINISHED SEBORRHEIC KERATOSIS SKIN LESIONS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| ALLERGIC REACTION: RASH ON THE FACE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| BLOODY NOSE | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| BLUE COLORED URINE | Renal and urinary disorders | Non-systematic Assessment |
| ||
| BLUE/GREEN COLORED URINE | Renal and urinary disorders | Non-systematic Assessment |
| ||
| BLURRING OF VISION | Eye disorders | Non-systematic Assessment |
| ||
| CANKER SORES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| CLEARED UP ACNE ON MY FOREHEAD | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| COLD | General disorders | Non-systematic Assessment |
| ||
| CONSTIPATION | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| COUGH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| DEEP BRUISED LFT LEG PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| DEPRESSION | Psychiatric disorders | Non-systematic Assessment |
| ||
| DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DIARRHEA-FREQUENT BM'S | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DIZZINESS | Nervous system disorders | Non-systematic Assessment |
| ||
| DRY & ITCHY SKIN | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| DRY EYE | Eye disorders | Non-systematic Assessment |
| ||
| DRY EYES | Eye disorders | Non-systematic Assessment |
| ||
| DRY ITCHY EYE | Eye disorders | Non-systematic Assessment |
| ||
| DRY MOUTH | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DRY SKIN | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| DRY SKIN AROUND NOSE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| DRY SKIN ON NOSE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| DRY SKIN-(LEGS) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| DRYNESS OF EYES | Eye disorders | Non-systematic Assessment |
| ||
| DRYNESS OF SKIN ON FACE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| DULL SORENESS IN LEG | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| EARACHE | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| FACE PIMPLES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| FACE SORE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| FATIGUE | General disorders | Non-systematic Assessment |
| ||
| FLATULENCE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| FLU | General disorders | Non-systematic Assessment |
| ||
| FOLLICULAR RASH ON TORSO | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| HEADACHE | Nervous system disorders | Non-systematic Assessment |
| ||
| HEARTBURN | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| INCARCERATED HERNIA | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| IRRITABLE-MOOD ALTERATION | Psychiatric disorders | Non-systematic Assessment |
| ||
| ITCHINESS OF EYES | Eye disorders | Non-systematic Assessment |
| ||
| LIGHT HEADED | Nervous system disorders | Non-systematic Assessment |
| ||
| LOOSE STOOLS | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| LOSS OF APPETITE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| LOTS OF GAS | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| MILD DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| MILD INDIGESTION | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| MILD RASH IN THE BUTTOCK | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| MOUTH SORES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| NOSE BLEED | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| PAIN ON ABDOMEN | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| PAIN ON FOOT | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| PAINFUL ITCHY & TENDER SCALP | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH ON CHEST | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH ON FACE, CHEST AND SHOULDER | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH ON FACE, CHEST, AND BEHIND EARS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH ON FACE, SCALP AND CHEST | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH ON FACE, SCALP, CHEST | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH ON FACE, SCALP, CHEST, BACK, EXTREMITIES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH ON FOOT | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RASH ON FOREHEAD/NOSE/CHEST | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RAW NOSE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RED ITCHY FACE RASH ON CHEEKS & NOSE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RED PUFFY EYES | Eye disorders | Non-systematic Assessment |
| ||
| RED RASH-FACE PEELING & NOW WHITE HEAD PIMPLES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RED RASH-FACE,NOSE, & CHEST | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RED RASH-FACE-NECK-CHEST & SCALP-ITCHY | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RED,BUMPY FACE & CHEST RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| RUNNY NOSE | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| SEEING BLACK SPOTS AND FLASHING LIGHTS IN LEFT EYE | Eye disorders | Non-systematic Assessment |
| ||
| SHORT OF BREATH EASILY | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| SHORT OF BREATH-DYSPNEA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| SORE THROAT | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| SWOLLEN FACE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| SWOLLEN LEFT KNEE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| ULCER ON MUCOUS MEMBRANE IN MOUTH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| VOMIT | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timothy R. Morgan | University of California, Irvine | 562-826-5756 | timothy.morgan@va.gov |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| OG002 |
| 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 The range of days on treatment is 7 to 23 days |
|
|
|
| OG002 | 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 The range of days on treatment is 7 to 23 days |
|
|
|
| OG002 |
| 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 The range of days on treatment is 7 to 23 days |
|
|
|
| OG002 | 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 The range of days on treatment is 7 to 23 days |
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