Trial Search Results

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

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)

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

George Albert Fisher

Collaborator: Bristol-Myers Squibb

Intervention(s):

  • Drug: Cetuximab
  • Drug: Oxaliplatin
  • Drug: Capecitabine
  • Radiation: Radiotherapy
  • Drug: Diphenhydramine hydrochloride (HCl)

Phase:

Phase 1/Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Heidi Kaiser
6507240079
Not Recruiting