Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

NCT00972881 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000648171CRUK-UCL-EXCITEEUDRACT-2007-006701-25EU-20964
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 5

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 cetuximab, 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 combination chemotherapy, cetuximab, 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 I/II trial is studying the side effects of giving capecitabine and irinotecan hydrochloride together with cetuximab and radiation therapy and to see how well it works in treating patients undergoing surgery for locally advanced rectal cancer.

Conditions

Rectal Cancer

Keywords

adenocarcinoma of the rectum; Locally advanced rectal cancer

Outcome Measures

Primary Outcomes (1)

• Histologically confirmed R0 resection rate

  Week 14 (6 weeks after treatment complete)

Secondary Outcomes (7)

• Radiotherapy compliance

  Weeks 2, 3, 4, 5 & 6

• Grade 3 or 4 toxicity as assessed by NCI CTCAE v3.0

  Baseline, week 1- 10, week 12 & 14 then at 6, 12, 24 & 36 months follow up

• Pathological complete response

  Week 14 (surgery conducted 6 weeks from end of treatment)

• Post-operative morbidity

  Week 14

• Long-term morbidity

  Week 14, then at 6, 12, 24 & 36 months follow up

Interventions

cetuximab BIOLOGICAL

capecitabine DRUG

irinotecan hydrochloride DRUG

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the rectum * MRI-defined locally advanced disease, as defined by 1 of the following: * Mesorectal fascia involvement * Mesorectal fascia threatened (tumor ≤ 1 mm from mesorectal fascia) * Any T3 tumor \< 5 cm from anal verge * No evidence of metastatic disease PATIENT CHARACTERISTICS: * ECOG or WHO performance status 0-1 * ANC ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Serum bilirubin \< 1.25 times upper limit of normal (ULN) * Serum transaminase(s) \< 3 times ULN * Serum alkaline phosphatase \< 5 times ULN * Estimated glomerular filtration rate \> 50 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception * Fit to receive all study treatments * Able to comply with oral medication * No comorbidity or coagulation problem that would deem the patient unsuitable for surgery * No pre-existing condition that would preclude radiotherapy (e.g., fistulas, severe ulcerative colitis \[particularly patients currently taking sulfasalazine\], Crohn's disease, prior adhesions) * No current or impending rectal obstruction (unless a defunctioning stoma is present) or metallic colonic rectal stent in situ * No significant small bowel delineated within the radiotherapy fields * No pelvic sepsis * No gastrointestinal disorder that would interfere with oral therapy or oral bioavailability * No uncontrolled cardiac, respiratory, or other disease that would preclude study therapy or informed consent * No serious medical or psychiatric disorder that would preclude study therapy or informed consent * No known dihydropyrimidine dehydrogenase deficiency PRIOR CONCURRENT THERAPY: * No prior chemotherapy * No prior radiotherapy to the pelvis * No concurrent participation in other studies, except genetic studies (e.g., NSCCG-National Study of Colorectal Cancer Genetics) * No concurrent St. John wort * No other concurrent cytotoxic treatment or radiotherapy

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

Sponsors & Collaborators

• University College, London: lead

Study Sites (5)

Yorkshire Regional Clinical Trials & Research Unit

Leeds, England, LS16 6QB, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

Rosemere Cancer Centre at Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Cancer Research UK and University College London Cancer Trials Centre

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

Related Links

• Clinical trial summary from the Cancer Research UK website

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Cetuximab; Capecitabine; Irinotecan; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal 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

• Simon Gollins, MD

  Glan Clwyd Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2009
• First Posted: September 9, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 31, 2016
• Last Updated: October 25, 2017

Record last verified: 2014-12

Locations

GB (5)