Stage IIIB Rectal Cancer Clinical Trial
Official title:
A Pilot Study of Paricalcitol Synergism in Conjunction With Standard-of-Care Chemo-Radiation for Resectable Rectal Cancers
This randomized pilot clinical trial studies the side effects of giving paricalcitol together with fluorouracil and radiation therapy in treating patients with rectal cancer that can be removed in surgery. Paricalcitol may help rectal cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. It not yet known if chemotherapy and radiation therapy are more effective with or without paricalcitol in treating rectal cancer
PRIMARY OBJECTIVES:
I. To evaluate toxicity and tolerability of oral paricalcitol at 2 μg/day when
co-administered with oral 5-fluorouracil (fluorouracil)-based chemoradiation in patients with
histologically confirmed, resectable T3-T4 adenocarcinoma of rectal mucosal origin or
node-positive disease with no known distant metastases.
SECONDARY OBJECTIVES:
I. To study the biologic effects of oral paricalcitol in addition to oral 5-fluorouracil
chemoradiation on Vitamin D receptor staining, MIB-1, Caspase 3, P 21, and Bax protein
expression in these patients.
II. To identify patterns of gene expression in tumor samples of patients who receive chemo
radiation with and without Paricalcitol supplementation using gene microarray technology.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paricalcitol orally (PO) daily. Patients also receive standard care
chemoradiotherapy with fluorouracil PO.
ARM II: Patients receive standard care chemoradiotherapy as in Arm I.
In both arms, treatment continues until surgical resection in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 month after surgery.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
Terminated |
NCT01934179 -
Telomere Length in Predicting Toxicity in Older Patients With Stage III-IV Colorectal Cancer Undergoing Chemotherapy
|
N/A | |
Completed |
NCT01740648 -
Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer
|
Phase 1 | |
Completed |
NCT00005036 -
Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
|
Phase 3 | |
Completed |
NCT01131234 -
Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT00003799 -
Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Rectal Cancer
|
Phase 1 | |
Completed |
NCT01643499 -
Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies
|
Phase 1 | |
Withdrawn |
NCT02287727 -
Regorafenib in Reducing Recurrence in Patients With Non-metastatic Rectal Cancer Who Have Completed Curative-Intent Treatment
|
Phase 2 | |
Completed |
NCT01802320 -
Akt Inhibitor MK2206 in Treating Patients With Previously Treated Colon or Rectal Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
|
Phase 2 | |
Completed |
NCT00060411 -
A Phase I, Pharmacological, and Biological Study of OSI-774 in Combination With FOLFOX 4 (5-FU, Leucovorin, and Oxaliplatin) and Bevacizumab (Avastin) in Patients With Advanced Colorectal Cancer
|
Phase 1 | |
Completed |
NCT02132858 -
Genetic Mutations in Blood and Tissue Samples in Predicting Response to Treatment in Patients With Locally Advanced Rectal Cancer Undergoing Chemoradiation
|
||
Completed |
NCT00754494 -
Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma
|
Phase 2 | |
Completed |
NCT02232152 -
CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
|
Phase 1 | |
Completed |
NCT01726296 -
Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care
|
N/A | |
Completed |
NCT01741636 -
Survivorship Care Planning in Patients With Colorectal or Non-Small Cell Lung Cancer
|
N/A | |
Completed |
NCT00103311 -
SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer
|
Phase 2 | |
Completed |
NCT02270606 -
Phase I Study of Neoadjuvant Radiotherapy With 5-Fluorouracil for Rectal Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03154190 -
Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
|
N/A | |
Terminated |
NCT04044430 -
Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer
|
Phase 1 | |
Completed |
NCT02148406 -
Programs to Support You During Chemotherapy (Pro-You)
|
N/A |