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Home > "S" Clinical Trials Conditions > Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer  Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
For Condition: recurrent rectal cancer,recurrent colon cancer,stage 4 colon cancer,Stage 4 rectal cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Thalidomide may stop the growth of colorectal cancer by stopping blood flow to the tumor. Giving thalidomide after surgery may kill any remaining tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of surgery with or without thalidomide in treating patients who have recurrent or metastatic colorectal cancer.
Details: OBJECTIVES: - Compare the disease-free survival probability in patients with previously resected recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs placebo. - Compare the time to recurrence in patients treated with these regimens. - Determine whether serum/plasma levels of vascular endothelial growth factor and basic fibroblast growth factor preresection and postresection correlate with tumor recurrence and determine if these levels, as well as CEA measurements, aid in predicting time to recurrence in these patients. - Determine the pharmacokinetics and toxicity of long-term thalidomide therapy in these patients. - Determine whether patients receiving thalidomide develop measurable antiangiogenic activity. - Measure the presence of circulating tumor cells preresection and postresection and determine if this type of analysis can be used to predict recurrence in this patient population. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to site of most recent lesion resection that rendered no evidence of disease (lung vs liver with no more than 3 lesions vs liver with more than 3 lesions vs lung and liver vs all other sites[including sites that were both resected and ablated]). Patients without evidence of residual disease are randomized to one of two treatment arms. - Arm I: Patients receive oral thalidomide once daily. - Arm II: Patients receive an oral placebo once daily. Treatment continues in both arms for 2 years in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for up to 3 years. PROJECTED ACCRUAL: A total of 94 patients (47 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of recurrent or metastatic colorectal carcinoma previously resected within 12 weeks of study entry - Surgical resection combined with radiofrequency ablation allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Hemoglobin at least 8.0 g/dL - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - PTT/PT no greater than 120% of control (except in therapeutically anticoagulated nonrelated medical conditions [e.g., atrial fibrillation]) - Total bilirubin no greater than 1.5 mg/dL (direct bilirubin no greater than 1.0 mg/dL for patients with Gilbert's syndrome) - AST/ALT less than 2.5 times normal - No history of hepatic cirrhosis - No concurrent hepatic dysfunction Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No severe congestive heart failure or active ischemic heart disease - No known history of deep vein thrombosis or pulmonary embolism (unless a foreign body implant was the direct cause [e.g., central venous catheters or portacaths]) Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for least 4 weeks before, during, and for at least 4 weeks after study participation - No history of severe hypothyroidism - No history of seizures - No significant history of other medical problems that would preclude surgery - No peripheral neuropathy greater than grade 1, except localized neuropathy due to a mechanical cause or trauma PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy Chemotherapy: - At least 4 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics Other: - No concurrent sedating drugs that cannot be reduced to a minimal level - No concurrent sedating recreational drugs or alcohol - No concurrent antiseizure medications
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenLibutti, Study Chair, Surgery Branch
University of Pittsburgh Medical Center *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting David Bartlett 412-692-2852
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Perry Shen 336-716-9389
Center for Cancer Care at Goshen Health System *Recruiting*
Goshen, Indiana, 46526
United States
Recruiting Richard Hostetter 574-535-2888
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0558
United States
Recruiting Joseph Buell 513-558-6010
Additional Information:
Study ID Numbers: CDR0000067098; PCI-020901,NCI-99-C-0102
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00019747
Other Stage 4 Rectal Cancer Studies:
1. Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
2. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
3. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
4. Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
5. Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
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