Recurrent Colon Cancer Clinical Trial
Official title:
A Phase I Evaluation of Cetuximab and RAD001 in Patients With Solid Tumors
This phase I trial studies the side effects and best dose of cetuximab when given together with everolimus in treating patients with metastatic or recurrent colon cancer or head and neck cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cetuximab together with everolimus may be an effective treatment for colon cancer or head and neck cancer
PRIMARY OBJECTIVES:
I. Determine the safety, dose-limiting toxicity and maximum tolerated dose of daily RAD001
(everolimus) when given in combination with a fixed dose of weekly cetuximab in patients
with solid tumors.
SECONDARY OBJECTIVES:
I. Determine whether a pharmacokinetic interaction exists between RAD001 and CETUXIMAB in
patients treated with this regimen.
II. Determine preliminary clinical evidence of anti-tumor activity by time to progression
and Response Evaluation Criteria in Solid Tumors (RECIST) criteria with this regimen.
III. Determine the association between clinical outcomes and biologic markers that may
predict sensitivity of a tumor in patients treated with this regimen.
IV. Determine the pharmacodynamic effects of this regimen on post-therapy tumor and/or skin
specimens.
OUTLINE: This is a dose-escalation study of everolimus.
Patients receive everolimus orally (PO) once daily (QD) on days -14 and then 1-28. Patients
also receive cetuximab intravenously (IV) over 60-120 minutes on days -7 and then once
weekly beginning on day 1. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months for at least 1
year.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 | |
| 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 |
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 | |
| 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 | |
| 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 | |
| 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 | |
| Completed |
NCT00028496 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT00005036 -
Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
|
Phase 3 | |
| Completed |
NCT01116687 -
RO4929097 in Treating Patients With Metastatic Colorectal Cancer
|
Phase 2 |