Know Cancer

forgot password

Phase II Study of Capecitabine, Oxaliplatin and Cetuximab Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma

Phase 2
18 Years
Not Enrolling
Rectal Cancer

Thank you

Trial Information

Phase II Study of Capecitabine, Oxaliplatin and Cetuximab Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma

Inclusion Criteria:

- Histologically confirmed nonmetastatic, measurable, locally advanced (T3 or T4)
rectal adenocarcinoma

- If available, tumor tissue must be sent for investigational immunohistochemical
evaluations of EGFR status

- The distal border of the tumor must be at or below the peritoneal reflection (defined
a with 12 cm of the anal verge by proctoscopy)

- Transmural penetration of the tumor demonstrated by CT + endorectal ultrasound or MRI

- ECOG PS 0-2

- No prior chemotherapy, biologic therapy or radiation therapy

- Age >= 18 years old

- Laboratory values: ANC >= 1500/mm3; Platelets >= 100,000/mm3; Hgb >= 9 g/dL;
Estimated CrCl > 50 mL/min; Serum bilirubin <= 1.5 x ULN; AST and ALT <= 3.0 x ULN;
Negative proteinuria based on dip stick reading

- Patients must either be not of child bearing potential or have a negative pregnancy
test upon study enrollment. Patients must agree to continue contraception for 30
days from the date of the last study drug administration.

Exclusion Criteria:

- Pregnant or lactating woman. Women of childbearing potential with either a positive
or no pregnancy test upon study enrollment. Women/men of childbearing potential not
using a reliable and appropriate contraceptive method. Patients must agree to
continue contraception for 30 days from the date of the last study administration.

- Life expectancy < 3 months

- Serious, uncontrolled, concurrent infection(s)

- Concurrent use of chemotherapy not indicated in the study protocol or any other
investigational agents and patients who have received investigational drugs < 4 weeks
prior to randomization.

- Prior therapy which specifically and directly targets the EGFR pathway.

- Prior severe infusion reaction to a monoclonal antibody

- Any prior therapy with Oxaliplatin

- Prior pelvic irradiation for any reason

- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity
to 5-fluorouracil or known DPD deficiency

- Treatment for other carcinomas within the last five years, except cured non-melanoma
skin and treated in-situ cervical cancer

- Participation in any investigational drug study within 4 weeks preceding the start of
the study treatment

- Major surgery within 4 weeks of the study treatment, without complete recovery

- Known, existing uncontrolled coagulopathy

- Unwillingness to give written informed consent

- Unwillingness to participate or inability to comply with the protocol for the
duration of the study

- Known allergy or hypersensitivity to platinum-containing drugs

- Peripheral sensory neuropathy with functional impairment

- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung

- Pleural effusions or ascites that causes respiratory compromise

- Acute hepatitis or known HIV

- Any of the following concurrent severe and/or uncontrolled medical conditions which
could compromise participation in the study: uncontrolled high blood pressure,
history of labile hypertension, or history of poor compliance with anti-hypertensive
regimen; unstable angina pectoris; symptomatic congestive heart failure; myocardial
infarction < 6 months prior to randomization; serious uncontrolled cardiac
arrhythmia; uncontrolled diabetes; active or uncontrolled infection; impairment of
gastrointestinal function or GI disease that may significantly alter the absorption
of Capecitabine.

- Evidence of CNS metastases or history of uncontrolled seizures, central nervous
system disorders or psychiatric disability judged by the investigator to be
clinically significant, precluding informed consent, or interfering with compliance
of oral drug intake.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response

Outcome Time Frame:

After neoadjuvant treatment

Safety Issue:


Principal Investigator

Daniel G Haller, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of University of Pennsylvania


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Rectal Cancer
  • Adjuvant therapy
  • Rectal cancer
  • Capecitabine
  • Oxaliplatin
  • Cetuximab
  • Erbitux
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms