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A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer

NCT ID: NCT00226941

Last Updated: 2017-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2009-02-28

Brief Summary

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The objectives of this study are to:

1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
2. To determine the maximum-tolerated dose (MTD) when capecitabine

* oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
3. To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination with capecitabine and radiotherapy (Phase 2)

Detailed Description

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Part of the treatment plan for this study is surgical removal of the tumor that is planned to occur 6 to 8 weeks after completion of radiotherapy (XRT). This study consists of 2 distinct phases (Phase 1 and Phase 2).

In Phase 1, the objectives are to

1. Assess dose-limiting toxicities (DLTs) and
2. Determine a maximum-tolerated dose (MTD)

The Phase 1 endpoints are assessed on an initial cohort of patients after the completion of the chemo-radiotherapy regimen at defined timepoints that precede surgery.

Phase 2 is the efficacy assessment portion of this study. In Phase 2, the objective is to accrue an expansion cohort. Efficacy assessments for phase 2 are to be assessed across all study participants at the time of, or after, surgery, as measured by the pathologic response rate; downstaging; and survival at 5 years from the start of treatment.

Conditions

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Rectal Cancer Colo-rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential design for 4 dose combinations (arms) through phase 1
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100

* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA)

Oxaliplatin

Intervention Type DRUG

Oxaliplatin is a cancer medication used to treat colorectal cancer, and is administered on Days 2 and 23.

Capecitabine

Intervention Type DRUG

Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses

Radiotherapy

Intervention Type RADIATION

Radiotherapy is administered on weekdays in 180 centigray fractions ("doses"), for 28 total fractions delivering a total dose of 5040 centigray (cGy)

Diphenhydramine hydrochloride (HCl)

Intervention Type DRUG

Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab

Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85

* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA)

Oxaliplatin

Intervention Type DRUG

Oxaliplatin is a cancer medication used to treat colorectal cancer, and is administered on Days 2 and 23.

Capecitabine

Intervention Type DRUG

Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses

Radiotherapy

Intervention Type RADIATION

Radiotherapy is administered on weekdays in 180 centigray fractions ("doses"), for 28 total fractions delivering a total dose of 5040 centigray (cGy)

Diphenhydramine hydrochloride (HCl)

Intervention Type DRUG

Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab

Group A - Cetuximab + Capecitabine-800 + XRT

* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA)

Capecitabine

Intervention Type DRUG

Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses

Radiotherapy

Intervention Type RADIATION

Radiotherapy is administered on weekdays in 180 centigray fractions ("doses"), for 28 total fractions delivering a total dose of 5040 centigray (cGy)

Diphenhydramine hydrochloride (HCl)

Intervention Type DRUG

Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab

Group B - Cetuximab + Capecitabine-1000 + XRT

* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA)

Capecitabine

Intervention Type DRUG

Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses

Radiotherapy

Intervention Type RADIATION

Radiotherapy is administered on weekdays in 180 centigray fractions ("doses"), for 28 total fractions delivering a total dose of 5040 centigray (cGy)

Diphenhydramine hydrochloride (HCl)

Intervention Type DRUG

Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab

Interventions

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Cetuximab

Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA)

Intervention Type DRUG

Oxaliplatin

Oxaliplatin is a cancer medication used to treat colorectal cancer, and is administered on Days 2 and 23.

Intervention Type DRUG

Capecitabine

Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses

Intervention Type DRUG

Radiotherapy

Radiotherapy is administered on weekdays in 180 centigray fractions ("doses"), for 28 total fractions delivering a total dose of 5040 centigray (cGy)

Intervention Type RADIATION

Diphenhydramine hydrochloride (HCl)

Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab

Intervention Type DRUG

Other Intervention Names

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Erbitux C225 IMC-C225 Eloxatin Xeloda XRT Benadryl Unisom Sominex

Eligibility Criteria

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Inclusion Criteria

* Histologically-confirmed adenocarcinoma of the rectum. Clinical stages T3; T4; or N1 as determined by endoscopic ultrasound; or a rectal CT or MRI scan are eligible, including T3 N0; T3 N1; T4 N0; T4 N1; T1-4 N1. Rectal cancers are defined as those whose distal border extends to within 12 cm of the anal verge.
* Age ≥ 18
* Karnofsky performance status (KPS) ≥ 70
* Leukocyte count \> 3,500 x 10e6/µL
* Platelet count \> 100,000/µL
* Serum glutamic-oxaloacetic transaminase (SGOT) \< 2.5 x institutional upper limits of normal (ULN)
* Serum glutamic-pyruvic transaminase (SGPT) \< 2.5 x ULN
* Alkaline phosphatase \< 2.5 x ULN
* Total bilirubin \< 1.5x ULN
* Creatinine:

* Within normal institutional limits
* OR
* Creatinine clearance \> 60 mL/min/1.73 m2 (if serum creatinine levels above institutional normal)
* Ability to swallow pills without difficulty
* Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG), within 72 hours prior to the start of study medication
* Women of child-bearing potential must be using an adequate method of contraception to avoid pregnancy throughout the treatment

Exclusion Criteria

* Metastatic (M1) or stage IV disease
* Prior history of treatment with cetuximab or other therapy targeting EGFR
* Prior history of anti-cancer murine monoclonal antibody therapy
* Prior pelvic or whole abdominal radiotherapy
* Uncontrolled intercurrent illness including, but not limited to:

* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness / social situations that would limit compliance with study requirements
* Patients with a concurrent malignancy or previous malignancy within 5 years of screening will be excluded from this study (EXCEPTION: concurrent or previous non-melanoma skin cancer, hematolymphoid malignancy or carcinoma in-situ of the cervix may be allowed at the investigator's discretion)
* Inability to sign written consent
* Pregnant or breastfeeding
* Unwilling or unable to use effective contraception in self or partner for the entire study period and for up to 4 weeks after the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

George Albert Fisher

OTHER

Sponsor Role lead

Responsible Party

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George Albert Fisher

Professor of Medicine and Colleen Haas Chair in the School of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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George A Fisher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Branimir I Sikic, MD

Role: STUDY_CHAIR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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COR0001

Identifier Type: OTHER

Identifier Source: secondary_id

95054

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-12426

Identifier Type: -

Identifier Source: org_study_id