Metastatic Colorectal Cancer Clinical Trial
Official title:
A Phase II/III Study of Dalotuzumab (MK-0646) Treatment in Combination With Cetuximab and Irinotecan for Patients With Metastatic Colorectal Cancer
This study will compare the safety and efficacy of dalotuzumab (MK-0646) in combination with
cetuximab and irinotecan in treating participants with wild type KRAS (wtKRAS) metastatic
colorectal cancer (CRC) compared to cetuximab and irinotecan alone.
The primary study hypothesis is that administration of dalotuzumab in combination with
cetuximab and irinotecan to participants with metastatic CRC expressing the wtKRAS genotype
improves Overall Survival OR Progression-free Survival compared to participants treated with
cetuximab and irinotecan alone.
Dalotuzumab is a humanized monoclonal antibody (mAb) that targets the insulin-like growth
factor type 1 receptor-1 (IGF-1R). Dalotuzumab may act through inhibition of insulin-like
growth factor-1 (IGF-1)-mediated cell signaling to cause reductions in tumor growth and
spread antibody dependent cell-mediated cytotoxicity.
In preclinical studies, dalotuzumab improved the activity of an anti-epidermal growth factor
receptor (EGFR) mAb and the activity of erlotinib, a small molecule inhibitor of EGFR.
All eligible participants will receive cetuximab 400 mg/m^2 infusion over 120 minutes
followed by weekly infusions of cetuximab 250 mg/m^2 over 60-120 minutes along with
irinotecan infusion over 30-90 minutes. Dosage of irinotecan will be the same as most recent
pre-study therapy. Participants will then be assigned to one of three treatment double-blind
arms.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01228734 -
A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients
|
Phase 3 | |
| Completed |
NCT05178745 -
A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
|
||
| Completed |
NCT01591421 -
P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer.
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05412706 -
Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
|
Phase 2 | |
| Withdrawn |
NCT04430985 -
FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| Withdrawn |
NCT03182894 -
Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05725200 -
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| Terminated |
NCT03176264 -
PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer
|
Phase 1 | |
| Completed |
NCT04866290 -
HepaSphere™ Microspheres Prospective Registry
|
||
| Not yet recruiting |
NCT06425133 -
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
|
Phase 2 | |
| Not yet recruiting |
NCT05531045 -
18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
|
||
| Withdrawn |
NCT03982173 -
Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors
|
Phase 2 | |
| Completed |
NCT02906059 -
Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT02575378 -
Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
|
Phase 4 | |
| Withdrawn |
NCT02535988 -
Abscopal Effect for Metastatic Colorectal Cancer
|
Phase 2 | |
| Recruiting |
NCT02848807 -
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
|
N/A | |
| Active, not recruiting |
NCT02077868 -
Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment
|
Phase 3 | |
| Completed |
NCT02414009 -
Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients
|
Phase 2 | |
| Active, not recruiting |
NCT01949194 -
Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers
|
Phase 2 | |
| Withdrawn |
NCT01915472 -
A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
|
Phase 2 |