Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| COR0001 | Other Identifier | OnCore | |
| 95054 | Other Identifier | Stanford IRB, historical |
Not provided
Not provided
Not provided
The response rate observed in the phase 1 portion of the study did not merit further evaluation in phase 2 portion of the study.
Not provided
Not provided
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
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The objectives of this study are to:
To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
To determine the maximum-tolerated dose (MTD) when capecitabine
To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination with capecitabine and radiotherapy (Phase 2)
Part of the treatment plan for this study is surgical removal of the tumor that is planned to occur 6 to 8 weeks after completion of radiotherapy (XRT). This study consists of 2 distinct phases (Phase 1 and Phase 2).
In Phase 1, the objectives are to
The Phase 1 endpoints are assessed on an initial cohort of patients after the completion of the chemo-radiotherapy regimen at defined timepoints that precede surgery.
Phase 2 is the efficacy assessment portion of this study. In Phase 2, the objective is to accrue an expansion cohort. Efficacy assessments for phase 2 are to be assessed across all study participants at the time of, or after, surgery, as measured by the pathologic response rate; downstaging; and survival at 5 years from the start of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 | Experimental |
|
|
| Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 | Experimental |
|
|
| Group A - Cetuximab + Capecitabine-800 + XRT | Experimental |
|
|
| Group B - Cetuximab + Capecitabine-1000 + XRT | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicity (DLT) - Number of DLTs by Treatment Group | Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of DLTs by treatment group. | 10 weeks |
| Dose-limiting Toxicity (DLT) - Number of Participants Affected | Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of participants experiencing a DLT. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Response Rate | After treatment with capecitabine, cetuximab, radiotherapy, and oxaliplatin, the pathologic response rate was assessed based on the excised tumor taken at the time of surgical resection. Pathologic response rate was determined as the number and proportion of participants who experienced either downstaging of their disease, or complete response (CR, no detectable disease). A participant will be considered to have downstaging of the tumor as a result of the neoadjuvant therapy when the primary tumor (T) stage by pathology isless than the T stage by clinical (endoscopic) evaluation, or when the regional lymph node (N) tumor stage by pathology is less than the N stage by clinical (endoscopic) evaluation. |
Not provided
INCLUSION CRITERIA
Histologically-confirmed adenocarcinoma of the rectum. Clinical stages T3; T4; or N1 as determined by endoscopic ultrasound; or a rectal CT or MRI scan are eligible, including T3 N0; T3 N1; T4 N0; T4 N1; T1-4 N1. Rectal cancers are defined as those whose distal border extends to within 12 cm of the anal verge.
Age ≥ 18
Karnofsky performance status (KPS) ≥ 70
Leukocyte count > 3,500 x 10e6/µL
Platelet count > 100,000/µL
Serum glutamic-oxaloacetic transaminase (SGOT) < 2.5 x institutional upper limits of normal (ULN)
Serum glutamic-pyruvic transaminase (SGPT) < 2.5 x ULN
Alkaline phosphatase < 2.5 x ULN
Total bilirubin < 1.5x ULN
Creatinine:
Ability to swallow pills without difficulty
Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG), within 72 hours prior to the start of study medication
Women of child-bearing potential must be using an adequate method of contraception to avoid pregnancy throughout the treatment
EXCLUSION CRITERIA
Metastatic (M1) or stage IV disease
Prior history of treatment with cetuximab or other therapy targeting EGFR
Prior history of anti-cancer murine monoclonal antibody therapy
Prior pelvic or whole abdominal radiotherapy
Uncontrolled intercurrent illness including, but not limited to:
Patients with a concurrent malignancy or previous malignancy within 5 years of screening will be excluded from this study (EXCEPTION: concurrent or previous non-melanoma skin cancer, hematolymphoid malignancy or carcinoma in-situ of the cervix may be allowed at the investigator's discretion)
Inability to sign written consent
Pregnant or breastfeeding
Unwilling or unable to use effective contraception in self or partner for the entire study period and for up to 4 weeks after the study
Not provided
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| George A Fisher, MD, PhD | Stanford University | Principal Investigator |
| Branimir I Sikic, MD | Stanford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 |
|
| FG001 | Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Sequential design for 4 dose combinations (arms) through phase 1
Not provided
Not provided
Not provided
Not provided
|
| Oxaliplatin | Drug | Oxaliplatin is a cancer medication used to treat colorectal cancer, and is administered on Days 2 and 23. |
|
|
| Capecitabine | Drug | Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses |
|
|
| Radiotherapy | Radiation | Radiotherapy is administered on weekdays in 180 centigray fractions ("doses"), for 28 total fractions delivering a total dose of 5040 centigray (cGy) |
|
|
| Diphenhydramine hydrochloride (HCl) | Drug | Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab |
|
|
| 12 to 14 weeks after radiotherapy |
| Tumor Downstaging at Surgical Resection | Downstaging means a reduction from the stage of disease observed at baseline to the stage of disease after treatment with cetuximab, radiotherapy, oxaliplatin, and capecitabine, as determined at the time of surgical removal of the tumor. Downstaging may be observed as improvements in tumor staging at the primary site of the tumor; in nearby (regional) lymph nodes; or in metastatic disease beyond the regional lymph nodes. This outcome specifically does not include participants that achieved a complete response, nor those that experienced no response or disease progression. | 12 to 14 weeks after radiotherapy |
| Time-to-Progression (TTP) | Time-to-progression was assessed as the time from the date of surgical resection to the appearance of either local disease recurrence or distant metastases by any modality (eg, clinical exam, endoscopy, radiographic imaging). All relapses were to be confirmed by biopsy and pathology review. | 5 years |
| Overall Survival (OS) | Overall Survival (OS) was assessed as the mean survival from the date of entry on study though 72 months. | 72 months |
| Survival at 5 Years | Survival at 5 years was assessed as the number of participants alive 5 years after starting treatment. | 5 years |
|
| FG002 | Group A - Cetuximab + Capecitabine-800 + XRT |
|
| FG003 | Group B - Cetuximab + Capecitabine-1000 + XRT |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 |
|
| BG001 | Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 |
|
| BG002 | Group A - Cetuximab + Capecitabine-800 + XRT |
|
| BG003 | Group B - Cetuximab + Capecitabine-1000 + XRT |
|
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Histology | 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 | Dose-limiting Toxicity (DLT) - Number of DLTs by Treatment Group | Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of DLTs by treatment group. | All participants were formally part of the phase 1 portion of this study. | Posted | Number | DLTs | 10 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Dose-limiting Toxicity (DLT) - Number of Participants Affected | Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of participants experiencing a DLT. | All participants were formally part of the phase 1 portion of this study. | Posted | Count of Participants | Participants | 10 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Pathologic Response Rate | After treatment with capecitabine, cetuximab, radiotherapy, and oxaliplatin, the pathologic response rate was assessed based on the excised tumor taken at the time of surgical resection. Pathologic response rate was determined as the number and proportion of participants who experienced either downstaging of their disease, or complete response (CR, no detectable disease). A participant will be considered to have downstaging of the tumor as a result of the neoadjuvant therapy when the primary tumor (T) stage by pathology isless than the T stage by clinical (endoscopic) evaluation, or when the regional lymph node (N) tumor stage by pathology is less than the N stage by clinical (endoscopic) evaluation. | This outcome is specifically defined per protocol as the phase 2 portion of the study, which did not occur. However, the data for this measure are available from the phase 1 participants (only), and are provided for completeness. | Posted | Count of Participants | Participants | 12 to 14 weeks after radiotherapy |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Downstaging at Surgical Resection | Downstaging means a reduction from the stage of disease observed at baseline to the stage of disease after treatment with cetuximab, radiotherapy, oxaliplatin, and capecitabine, as determined at the time of surgical removal of the tumor. Downstaging may be observed as improvements in tumor staging at the primary site of the tumor; in nearby (regional) lymph nodes; or in metastatic disease beyond the regional lymph nodes. This outcome specifically does not include participants that achieved a complete response, nor those that experienced no response or disease progression. | This outcome is specifically defined per protocol as the phase 2 portion of the study, which did not occur. However, the data for this measure are available from the phase 1 participants (only), and are provided for completeness. | Posted | Count of Participants | Participants | 12 to 14 weeks after radiotherapy |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time-to-Progression (TTP) | Time-to-progression was assessed as the time from the date of surgical resection to the appearance of either local disease recurrence or distant metastases by any modality (eg, clinical exam, endoscopy, radiographic imaging). All relapses were to be confirmed by biopsy and pathology review. | This study was terminated before all patients reached 5 years from the date of surgical resection. Only patients that progressed are reported, and since no patients progressed in Group 2, median and range are not reportable. | Posted | Median | Full Range | years | 5 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) was assessed as the mean survival from the date of entry on study though 72 months. | This outcome is defined per protocol as study phase 2, which did not occur. However, data are provided for phase 1 participants, for completeness. This study was terminated before all patients reached 5 years on study. Some patients are reported as the last known alive date. | Posted | Mean | Standard Deviation | months | 72 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Survival at 5 Years | Survival at 5 years was assessed as the number of participants alive 5 years after starting treatment. | This outcome is defined per protocol as study phase 2, which did not occur. However, data are available from the phase 1 participants (only), and are provided for completeness. This study was terminated before all patients reached 5 years from study entry. Only patients known to be alive at 5 years are reported. | Posted | Count of Participants | Participants | 5 years |
|
5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 |
| 1 | 6 | 6 | 6 | 6 | 6 |
| EG001 | Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 |
| 1 | 6 | 6 | 6 | 6 | 6 |
| EG002 | Group A - Cetuximab + Capecitabine-800 + XRT |
| 0 | 4 | 3 | 4 | 4 | 4 |
| EG003 | Group B - Cetuximab + Capecitabine-1000 + XRT |
| 0 | 7 | 7 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decrease in lung volumes with increased bibasilar atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Small bowel obstruction-Ileus | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Nausea | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cramping | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Allergic reaction | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Libido | Reproductive system and breast disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Edema | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Fatigue | Immune system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Insomnia | Investigations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Rigors | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Fever | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hemorrhage in rectum | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Syncope | Investigations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Depression | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Backache | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Bilateral jaw pain | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Distension | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Bloody stool | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Bloody rectum | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Body aches | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Candidal infection | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Chest tightness | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Cold sensitivity | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Constipation, alternating with diarrhea | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Skin cracking | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Cramping | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Cuticle dryness | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dehydration | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Diarrhea with cramping | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Elevated alanine aminotransferase (ALT) | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Elevated aspartate aminotransferase (AST) | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Erythema at incision | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Flatus | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Flu-like symptoms | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Flushing | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Rash, follicular, chest and back | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain, groin | Injury, poisoning and procedural complications | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hand and foot syndrome | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hypokalemia | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hypomagnesemia | Endocrine disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Induration | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Injection site reaction | Injury, poisoning and procedural complications | CTCAE 3.0 | Non-systematic Assessment |
| |
| Left arm numbness | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain, left knee | Injury, poisoning and procedural complications | CTCAE 3.0 | Non-systematic Assessment |
| |
| Lightheadedness | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Abnormal liver function test (LFT) | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain, lower back | Injury, poisoning and procedural complications | CTCAE 3.0 | Non-systematic Assessment |
| |
| Low grade fever | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hematocrit decreased | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Migraine | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Nocturia | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain with bowel movements | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Weight loss | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Infection, urinary track (UTI) | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Urinary hesitancy | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Infection, upper respiratory tract | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain, umbilical cord protrusion | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Tingling, fingertips | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Tingling, cheeks | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Taste disturbance | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Skin dryness | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Blood in stool, scant | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Neuropathy, right arm | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Reflux | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Infection, rectal-anal | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Radiation demititis | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain (t11-12 level) | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain, bladder and testes | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain, middle ear | Ear and labyrinth disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain, throat | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
|
This trial was halted after the phase 1 portion of enrollment, and before the phase 2 portion accrued.
Data reported for phase 2 objectives/outcomes do not include any phase 2 participants, and are only provided for completeness.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Albert Fisher, Jr, MD, PhD; Colleen Haas Chair, School of Medicine | Stanford Cancer Institute, Stanford University | 650-723-2990 | georgeaf@stanford.edu |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D011878 | Radiotherapy |
| D004155 | Diphenhydramine |
| D004319 | Doxylamine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011725 | Pyridines |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Adenocarcinoma, Nos |
|
| Adenosarcoma |
|
| Group B - Cetuximab + Capecitabine-1000 + XRT |
|
|
|
| OG002 | Group A - Cetuximab + Capecitabine-800 + XRT |
|
| OG003 | Group B - Cetuximab + Capecitabine-1000 + XRT |
|
|
|
| Group A - Cetuximab + Capecitabine-800 + XRT |
|
| OG003 | Group B - Cetuximab + Capecitabine-1000 + XRT |
|
|
|
| OG003 |
| Group B - Cetuximab + Capecitabine-1000 + XRT |
|
|
|
|
|
|
|
|
|