Capecitabine, Panitumumab, and Radiation Therapy With or Without Irinotecan Hydrochloride in Treating Patients Undergoing Surgery for Localized Rectal Cancer

Part of paid clinical trials in Redlands, California.

Sponsor
Loma Linda Oncology Medical Group, Inc.
Study ID
NCT00967655
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • panitumumab — BIOLOGICAL
  • capecitabine — DRUG
  • irinotecan hydrochloride — DRUG
  • neoadjuvant therapy — PROCEDURE
  • therapeutic conventional surgery — PROCEDURE
  • radiation therapy — RADIATION

Study Details

RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy, monoclonal antibody therapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying the side effects of giving capecitabine and panitumumab together with radiation therapy with or without irinotecan hydrochloride and to see how well it works in treating patients undergoing surgery for localized rectal cancer.

Key Dates

Start date
Jul 31, 2009
Status verified
Sep 2009
Primary completion
Jul 31, 2012

Study Design

Enrollment
54 participants (estimated)
Primary purpose
TREATMENT

Primary Outcome Measure

Pathological complete response rate

Locations (4)

FacilityCityStateZIPSite coordinators
Davood Vafai, MD, Medical Offices, IncorporatedRedlandsCalifornia92374
Pedro Bernal, MD
909-796-4333
Loma Linda Oncology Medical Group, IncorporatedRedlandsCalifornia92374
Pedro Bernal, MD
909-796-4333
New Hope Cancer and Research Institute - GlendoraRedlandsCalifornia92374
Pedro Bernal, MD
909-796-4333
New Hope Cancer and Research Institute - PomonaRedlandsCalifornia92374
Pedro Bernal, MD
909-796-4333

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