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

Primary Purpose

Rectal Cancer

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

cetuximab

capecitabine

irinotecan hydrochloride

neoadjuvant therapy

therapeutic conventional surgery

radiation therapy

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring adenocarcinoma of the rectum, Locally advanced rectal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yorkshire Regional Clinical Trials & Research Unit
Christie Hospital
Clatterbridge Centre for Oncology
Rosemere Cancer Centre at Royal Preston Hospital
Cancer Research UK and University College London Cancer Trials Centre

Outcomes

Primary Outcome Measures

Histologically confirmed R0 resection rate

Secondary Outcome Measures

Radiotherapy compliance

Radiotherapy treatment and dosage is captured on weekly CRFs from week 2-6

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

Adverse events are recorded weekly on CRFs from week 1 of treatment until 4 weeks post treatment, then at 1 month post surgery and specified time points during long term follow up at 6, 12, 24 & 36 month intervals.

Pathological complete response

Post-operative morbidity

Long-term morbidity

Disease-free survival

Local failure-free survival

Full Information

NCT ID

NCT00972881

First Posted

September 5, 2009

Last Updated

October 24, 2017

Sponsor

University College, London

1. Study Identification

Unique Protocol Identification Number

NCT00972881

Brief Title

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

Acronym

EXCITE

Official Title

EXCITE: Erbitux, Xeloda, Campto, Irradiation Then Excision for Locally Advanced Rectal Cancer (North West Clinical Oncology Group-04 on Behalf of the NCRI Rectal Cancer Subgroup)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University College, London

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

OBJECTIVES: To assess the downstaging effectiveness and tolerability of neoadjuvant chemoradiotherapy comprising capecitabine, irinotecan hydrochloride, cetuximab, and radiotherapy in patients with locally advanced rectal cancer. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-6 and irinotecan hydrochloride IV over 1 hour once weekly in weeks 2-5. Patients also undergo pelvic radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 in weeks 2-6. Patients undergo surgery 8 weeks after completion of chemoradiotherapy. After completion of study treatment, patients are followed up at 6, 12, 24, and 36 months. Peer Reviewed and Funded or Endorsed by Cancer Research United Kindom (UK).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

adenocarcinoma of the rectum, Locally advanced rectal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

cetuximab

Intervention Type

Drug

Intervention Name(s)

capecitabine

Intervention Type

Drug

Intervention Name(s)

irinotecan hydrochloride

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant therapy

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Primary Outcome Measure Information:

Title

Histologically confirmed R0 resection rate

Time Frame

Week 14 (6 weeks after treatment complete)

Secondary Outcome Measure Information:

Title

Radiotherapy compliance

Description

Radiotherapy treatment and dosage is captured on weekly CRFs from week 2-6

Time Frame

Weeks 2, 3, 4, 5 & 6

Title

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

Description

Time Frame

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

Title

Pathological complete response

Time Frame

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

Title

Post-operative morbidity

Time Frame

Week 14

Title

Long-term morbidity

Time Frame

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

Title

Disease-free survival

Time Frame

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

Title

Local failure-free survival

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Gollins, MD

Organizational Affiliation

Glan Clwyd Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yorkshire Regional Clinical Trials & Research Unit

City

Leeds

State/Province

England

ZIP/Postal Code

LS16 6QB

Country

United Kingdom

Facility Name

Christie Hospital

City

Manchester

State/Province

England

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Clatterbridge Centre for Oncology

City

Merseyside

State/Province

England

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

Rosemere Cancer Centre at Royal Preston Hospital

City

Preston

State/Province

England

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

Cancer Research UK and University College London Cancer Trials Centre

City

Rhyl, Denbighshire

State/Province

Wales

ZIP/Postal Code

LL 18 5UJ

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-cetuximab-capecitabine-and-irinotecan-with-radiotherapy-before-surgery-for-cancer-of-the-rectum

Description

Clinical trial summary from the Cancer Research UK website

Learn more about this trial

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

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