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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU-59202 | |||
| CCCWFU-BG02-406 | |||
| CELGENE-CCCWFU-59202 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving thalidomide after surgery and chemotherapy may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well thalidomide works in treating patients who have undergone surgery and received chemotherapy directly into the abdomen by hyperthermic perfusion for cancer that has spread throughout the abdomen due to colorectal cancer or appendix cancer .
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral thalidomide once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemo therapy followed by thalidomide | Experimental | After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thalidomide | Drug | Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | Time to progression after surgery was recorded. | 9 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 60 months after treatment | |
| Number of Events of Toxicity Graded 3 and 4 | Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported | up to 60 months |
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DISEASE CHARACTERISTICS:
Pathologically confirmed peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer
Underwent cytoreductive surgery and intraperitoneal hyperthermic chemotherapy (IPHC) within the past 12 weeks
No extra-abdominal disease or parenchymal liver metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Perry Shen, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemo Therapy Followed by Thalidomide | After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| surgery | Procedure | Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemo Therapy Followed by Thalidomide | After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected. |
| 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 |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Time to Progression | Time to progression after surgery was recorded. | Posted | Median | 95% Confidence Interval | years | 9 hours |
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| Secondary | Progression Free Survival | Posted | Median | 95% Confidence Interval | years | 60 months after treatment |
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| |||||||||||||||||||||||||||
| Secondary | Number of Events of Toxicity Graded 3 and 4 | Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported | Posted | Number | number of events | up to 60 months |
|
|
up to 60 months
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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 | Chemo Therapy Followed by Thalidomide | After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected. | 15 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Dysrhythmias | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiovascular/General-other | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysphagia, esophagitis, odynophagia | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| other gastrointestinal | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemoglobin | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hemorrhage | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertension | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypomagnesemia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoxia | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection with unknown ANC | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Infection/Febrile Neutropenia-Other | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuro-mood | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuro-motor | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neurosensory | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain-other | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis/Embolism | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ureteral Obstruction | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight Gain | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytes | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alk Phos | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Alopecia | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Absolute Neutrophil Count | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness/vertigo | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neurologic Other | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dermatological | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight Loss | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Hypoglycemia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Hyponatremia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Coagulation Other | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Hot flashes/flushes | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Endocrine Other | Endocrine disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Serum glutamic pyruvic transaminase | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Somnolence | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Serum glutamic oxaloacetic transaminase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperkalemia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypernatremia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Fever in the absence of neutropenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Infection-Other | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Auditory/Ear-Other | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greg Russell, MS | Comprehensive Cancer Center of Wake Forest University | 336-716-5449 | grussell@wakehealth.edu |
| ID | Term |
|---|---|
| D001063 | Appendiceal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D002430 | Cecal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D003108 | Colonic Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Title | Denominators | Categories |
|---|
| Grade 3 |
| |||||
| Grade 4 |
|