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Phase II Trial of Cetuximab Plus Cisplatin, 5- Fluorouracil and Radiation in Immunocompetent Patients With Anal Carcinoma

Phase 2
18 Years
Open (Enrolling)
Anal Cancer

Thank you

Trial Information

Phase II Trial of Cetuximab Plus Cisplatin, 5- Fluorouracil and Radiation in Immunocompetent Patients With Anal Carcinoma



- Determine whether the addition of cetuximab to combined modality therapy (CMT)
comprising cisplatin, fluorouracil, and radiotherapy reduces the local failure rate by
≥ 50% at 3 years (compared with historical data) in immunocompetent patients with stage
I-IIIB invasive anal carcinoma.


- Determine objective response rate (complete and partial), progression-free survival,
relapse-free survival, colostomy-free survival, and overall survival.

- Determine the overall toxicity of concurrent cisplatin, fluorouracil, and radiation
therapy combined with cetuximab.

- Evaluate the effect of cetuximab and CMT on anogenital herpes papilloma virus (HPV)
infection and anal cytology.

- Evaluate whether moderate to strong expression of epidermal growth factor receptor,
PI3K, and P-Akt (as determined by immunohistochemistry) is associated with an increased
risk of local failure.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment arms.

- Arm I (closed to accrual as of 11/3/2008): Patients receive cisplatin IV over 60
minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on
days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes
on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and
undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57.
Treatment continues in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60
minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over
60 minutes on days 8 and 36, fluorouracil IV continuously over 96 hours on days 8-11
and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on
day 8. Treatment continues in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed anal canal or perianal (anal margin) squamous cell carcinoma

- Stage I-IIIB (closed to accrual as of 11/3/2008)

- Stage II (T3, N0 only), IIIA, or IIIB

- Tumors of nonkeratinizing histology, such as basaloid, transitional cell, or
cloacogenic histology, allowed

- No well-differentiated stage I anal margin cancer


- ECOG performance status 0-2

- Hemoglobin ≥ 10 g/dL

- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance > 60

- Bilirubin ≤ 2 times ULN

- AST and ALT < 3 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment

- No other malignancies except nonmelanomatous skin cancer

- Prior malignancies must be in remission for ≥ 5 years

- None of the following conditions within the past 6 months:

- Active infection

- Uncontrolled diabetes

- New York Heart Association class II-IV congestive heart failure

- Cerebrovascular accident

- Transient ischemic attack

- Uncontrolled hypertension

- Unstable angina

- Myocardial infarction

- No history of rheumatic disorders, irritable bowel syndrome, or inflammatory bowel

- No known HIV positivity

- No known risk factors for HIV infection

- Patients with a known risk factor for HIV infection must undergo HIV testing
within 90 days before study entry AND must be HIV negative by antibody
detection, culture, or quantitative assay of plasma HIV RNA


- No prior radiotherapy or chemotherapy for this malignancy

- No prior pelvic radiotherapy

- No prior potentially curative surgery (i.e., abdominal or peritoneal resection) for
anal cancer

- No concurrent intensity-modulated radiotherapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local failure rate at 3 years

Safety Issue:


Principal Investigator

Madhur K. Garg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Montefiore Medical Center



Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Anal Cancer
  • squamous cell carcinoma of the anus
  • stage I anal cancer
  • stage II anal cancer
  • stage IIIA anal cancer
  • stage IIIB anal cancer
  • basaloid carcinoma of the anus
  • cloacogenic carcinoma of the anus
  • Anus Neoplasms



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