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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00967655
First received: August 27, 2009
Last updated: January 9, 2014
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Biological: panitumumab
Drug: capecitabine
Drug: irinotecan hydrochloride
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Radiation in Combination With Capecitabine & Paniumumab With and Without Irinotecan in Patients With Localized Rectal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathological complete response rate [ Designated as safety issue: No ]
  • Grade 3/4 toxicity rate [ Designated as safety issue: Yes ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • 1-year survival rate [ Designated as safety issue: No ]
  • 2-year survival rate [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: July 2009
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To assess the pathological tumor response rate in patients with localized rectal cancer treated with neoadjuvant chemoradiotherapy comprising capecitabine, panitumumab, and radiotherapy with or without irinotecan hydrochloride.
  • To assess the incidence of grade 3/4 toxicity during neoadjuvant chemoradiotherapy.

Secondary

  • To assess the disease-free survival.
  • To assess the time to treatment failure.
  • To assess the1-year and 2-year survival rates.
  • To assess local recurrence, defined as recurrence in pelvis at the site of previous disease.
  • To assess the safety and toxicity grade using NCI CTCAE v3.0 criteria.
  • To assess the number and percentage of patients who undergo down staging of their disease as determined before initiating neoadjuvant therapy and at the time of surgery.
  • To assess the number and percentage of patients where permanent colostomy can be avoided as determined by the surgeon before initiating neoadjuvant therapy and at the time actual surgery is performed.

OUTLINE: This is a multicenter study.

  • Phase A: Patients undergo radiotherapy once daily 5 days a week and receive oral capecitabine twice daily 5 days a week for 5½ weeks. Patients also receive panitumumab IV over 1 hour on days 1, 15, and 29 during radiotherapy in the absence of disease progression or unacceptable toxicity.
  • Phase B: Patients undergo radiotherapy and receive capecitabine and panitumumab as in Phase A. Patients also receive irinotecan hydrochloride IV on days 1, 8, 22, and 29 in the absence of disease progression or unacceptable toxicity.

Patients undergo surgery 6-8 weeks after completion of chemoradiotherapy,

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the distal rectum (0-9 cm from the dentate line or 3-12 cm from the anal verge)
  • T3 or T4 tumor or nodal involvement by endorectal ultrasound or CT scan or MRI

    • Patients with any T status where tumor is close to but not involving the sphincter who otherwise would be candidates for abdominoperineal resection are eligible
  • No known homozygotes to UGT1A1* 28
  • No distant metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 3 times ULN
  • Serum creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 50 mL/min
  • Magnesium normal
  • Able to tolerate major surgery
  • Able and willing to comply with study requirements
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks (males) or 24 weeks (females) after completion of study therapy
  • No prior diagnosis of interstitial lung disease
  • No prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil
  • No other prior or concurrent invasive malignancy unless disease-free for ≥ 5 years
  • No lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets, or malabsorption syndrome
  • No concurrent serious infections
  • No clinically significant cardiovascular disease within the past year, including any of the following:

    • Myocardial infarction
    • Unstable angina
    • Symptomatic congestive heart failure
    • Symptomatic coronary artery disease
    • Serious uncontrolled cardiac arrhythmia
  • No history of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase risks associated with study participation or investigational product(s) administration or may interfere with the interpretation of the study results
  • No known positivity for HIV, hepatitis C, or acute or chronic active hepatitis B

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for rectal cancer
  • No prior anti-EGFr antibody therapy (e.g., cetuximab)
  • No prior treatment with small molecule EGFr inhibitors (e.g., gefitinib, erlotinib hydrochloride, or lapatinib ditosylate)
  • No prior therapeutic radiotherapy to the pelvis
  • More than 28 days since prior major surgery
  • More than 14 days since prior minor surgery
  • At least 30 days since prior investigational agent or therapy
  • At least 4 weeks since prior and no concurrent sorivudine or brivudine
  • No concurrent chronic immunosuppressive agents (e.g., methotrexate or cyclosporine)
  • No concurrent cimetidine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967655

Locations
United States, California
Davood Vafai, MD, Medical Offices, Incorporated Recruiting
Redlands, California, United States, 92374
Contact: Pedro Bernal, MD    909-796-4333      
Loma Linda Oncology Medical Group, Incorporated Recruiting
Redlands, California, United States, 92374
Contact: Pedro Bernal, MD    909-796-4333      
New Hope Cancer and Research Institute - Glendora Recruiting
Redlands, California, United States, 92374
Contact: Pedro Bernal, MD    909-796-4333      
New Hope Cancer and Research Institute - Pomona Recruiting
Redlands, California, United States, 92374
Contact: Pedro Bernal, MD    909-796-4333      
Sponsors and Collaborators
Loma Linda Oncology Medical Group, Incorporated
Investigators
Principal Investigator: Imtiaz A. Malik, MD Loma Linda Oncology Medical Group, Incorporated
  More Information

Additional Information:
No publications provided

Responsible Party: Imtiaz A. Malik, Loma Linda Oncology Medical Group, Incorporated
ClinicalTrials.gov Identifier: NCT00967655     History of Changes
Other Study ID Numbers: CDR0000652936, LLOMGI-20050743, MALIK 012009
Study First Received: August 27, 2009
Last Updated: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the rectum
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Camptothecin
Capecitabine
Irinotecan
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014