Recurrent Rectal Cancer Clinical Trial
Official title:
A Phase I Clinical Trial of MEK162 in Combination With FOLFOX in Patients With Advanced Metastatic Colorectal Cancer Who Failed Prior Standard Therapy
This phase I trial studies the side effects and best dose of MEK inhibitor MEK162 when given together with leucovorin calcium, fluorouracil, and oxaliplatin in treating patients with advanced metastatic colorectal cancer. MEK inhibitor MEK162 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving MEK inhibitor MEK162 with leucovorin calcium, fluorouracil, and oxaliplatin may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) for the combination of MEK162 (MEK inhibitor
MEK162) plus leucovorin calcium, fluorouracil, oxaliplatin (FOLFOX) in patients with
metastatic colorectal cancer.
SECONDARY OBJECTIVES:
I. Describe the safety of the combination of MEK162 across all investigated dose levels.
II. Describe the pharmacokinetics of MEK162 and FOLFOX in 6 patients in the expanded MTD
cohort.
III. Describe any clinical activity to the combination using Response Evaluation Criteria in
Solid Tumors (RECIST) 1.1 criteria.
IV. Determine the recommended Phase II dose (RP2D) which may be less than the MTD for both
intermittent and continuous dosing of MEK162.
OUTLINE: This is a dose-escalation study of MEK inhibitor MEK162. Patients are assigned to 1
of 2 treatment arms.
ARM I: Patients receive MEK inhibitor MEK162 orally (PO) twice daily (BID) on days 1-14, and
leucovorin calcium intravenously (IV) over 2 hours, oxaliplatin IV over 2 hours, and
fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in
the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive MEK inhibitor MEK162 PO BID on days 1-5, and leucovorin calcium IV
over 2 hours, oxaliplatin IV over 2 hours, and fluorouracil IV continuously over 46 hours on
days 6 and 7. Courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01987726 -
Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
|
||
Active, not recruiting |
NCT00826540 -
Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
Completed |
NCT00025337 -
Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
|
Phase 3 | |
Recruiting |
NCT04642924 -
SGM-101 in Locally Advanced and Recurrent Rectal Cancer
|
Phase 2/Phase 3 | |
Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
Completed |
NCT01217450 -
Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors
|
Phase 1 | |
Completed |
NCT01191684 -
Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer
|
Phase 1 | |
Terminated |
NCT01285102 -
Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer
|
Phase 1 | |
Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT01238965 -
Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy
|
Phase 1 | |
Completed |
NCT01037790 -
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
|
Phase 2 | |
Completed |
NCT00551421 -
Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00407654 -
VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer
|
Phase 2 | |
Completed |
NCT00091182 -
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
|
Phase 2 | |
Terminated |
NCT00052585 -
Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
|
Phase 2 | |
Completed |
NCT00023933 -
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
|
Phase 1 | |
Not yet recruiting |
NCT05076305 -
PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting
|
||
Completed |
NCT01740648 -
Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer
|
Phase 1 | |
Terminated |
NCT00397878 -
AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer
|
Phase 2 | |
Completed |
NCT00100841 -
Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer
|
Phase 2 |