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

NCT00967655 | Unknown Phase 2

• 3 other identifiers: CDR0000652936LLOMGI-20050743MALIK 012009
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the rectum; stage I rectal cancer; stage II rectal cancer; stage III rectal cancer

Outcome Measures

Primary Outcomes (6)

• Pathological complete response rate

• Grade 3/4 toxicity rate

• Disease-free survival

• Time to treatment failure

• 1-year survival rate

• 2-year survival rate

Interventions

panitumumab BIOLOGICAL

capecitabine DRUG

irinotecan hydrochloride DRUG

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Loma Linda Oncology Medical Group, Inc.: lead

Study Sites (4)

Davood Vafai, MD, Medical Offices, Incorporated

Redlands, California, 92374, United States

RECRUITING

Loma Linda Oncology Medical Group, Incorporated

Redlands, California, 92374, United States

RECRUITING

New Hope Cancer and Research Institute - Glendora

Redlands, California, 92374, United States

RECRUITING

New Hope Cancer and Research Institute - Pomona

Redlands, California, 92374, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Panitumumab; Capecitabine; Irinotecan; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids; Combined Modality Therapy; Therapeutics

Study Officials

• Imtiaz A. Malik, MD

  Loma Linda Oncology Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Last Updated: January 10, 2014

Record last verified: 2009-09

Locations

US (4)