Colorectal Cancer Clinical Trial
Official title:
A Phase II Trial of Oral Thalidomide as an Adjuvant Agent Following Metastasectomy in Patients With Recurrent Colorectal Cancer
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: This randomized phase II trial is studying surgery and thalidomide to see how well
they work compared to surgery alone in treating patients with recurrent or metastatic
colorectal cancer.
Status | Terminated |
Enrollment | 39 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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: - Partial thromboplastin time (PTT)/prothrombin time (PT) no greater than 120% of control (except in therapeutically anticoagulated nonrelated medical conditions [e.g., atrial fibrillation]) - Total bilirubin no greater than 2.0 mg/dL (direct bilirubin no greater than 1.0 mg/dL for patients with Gilbert's syndrome) - Aspartate aminotransferase (AST)/alanine aminotransferase (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 active clots within 1 year before diagnosis OR must be receiving concurrent treatment with anticoagulant (e.g., low molecular weight heparin or equivalent agent) 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: - See Cardiovascular - No concurrent sedating drugs that cannot be reduced to a minimal level - No concurrent sedating recreational drugs or alcohol - No concurrent antiseizure medications |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Suburban Hospital Cancer Program | Bethesda | Maryland |
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland |
United States | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio |
United States | Center for Cancer Care at Goshen Health System | Goshen | Indiana |
United States | UPMC Cancer Center at UPMC Presbyterian | Pittsburgh | Pennsylvania |
United States | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Progression | Time to progression was measured from the on study date until the date of progression or last follow up. Progression was assessed by the Response Evaluation Criteria for Solid Tumors (RECIST).Progressive Disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions | 62 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |