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A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer

Phase 1/Phase 2
18 Years
85 Years
Not Enrolling
Cervical Cancer

Thank you

Trial Information

A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer


- Determine treatment-related toxicity rates in patients with locally advanced cervical
cancer treated with external beam radiotherapy and brachytherapy concurrently with
celecoxib, fluorouracil, and cisplatin.

- Determine whether this regimen increases locoregional control rates, distant control,
disease-free survival, and overall survival in these patients.

- Determine whether first-failure patterns in patients treated with this regimen are
changed compared to historical controls.

OUTLINE: This is a multicenter study.

Patients undergo external beam pelvic radiotherapy once daily five days a weeks for 5 weeks
beginning on day 1. Within 8 weeks, patients undergo low-dose or high-dose brachytherapy.
Patients also receive concurrent chemotherapy comprising fluorouracil IV continuously over
days 2-5, 23-26, and 44-47 and cisplatin IV over 4 hours on days 1, 22, and 43. Oral
celecoxib is administered twice daily beginning on day 1 and continuing for 12 months.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1.5 years.

Inclusion Criteria


- Histologically confirmed squamous, adenocarcinoma, or adenosquamous carcinoma of the

- Stage IIB-IVA OR

- Stage IB-IIA with pelvic node metastases and/or tumor size at least 5 cm

- No small cell, carcinoid, glassy cell, clear cell, or adenoid cystic disease

- No metastatic disease outside of pelvis

- No para-aortic disease



- 18 to 85

Performance status:

- Zubrod 0-2

Life expectancy:

- At least 6 months


- WBC at least 3,000/mm^3

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- AST or ALT no greater than 2.5 times upper limit of normal (ULN)


- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 50 mL/min

- Calcium no greater than 1.3 times ULN


- No severe heart disease


- Not pregnant or nursing

- Negative pregnancy test

- HIV negative

- No prior allergy to sulfonamides or non-steroidal anti-inflammatory drugs (NSAIDs)

- No prior hypersensitivity to celecoxib or any component of its formulation

- No medical or psychiatric illness that would preclude study

- No active gastrointestinal (GI) ulcer, GI bleeding, or inflammatory bowel disease

- No other prior malignancy within the past 5 years except cutaneous basal cell skin


Biologic therapy:

- No recent prior celecoxib or other cyclo-oxygenase-2 inhibitor


- No prior systemic chemotherapy

Endocrine therapy:

- Not specified


- No prior radiotherapy to pelvis except transvaginal radiotherapy to control bleeding


- No prior surgery for cervical cancer except biopsy


- No concurrent phenytoin or lithium

- No other concurrent NSAIDs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David K. Gaffney, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Utah


United States: Federal Government

Study ID:




Start Date:

August 2001

Completion Date:

Related Keywords:

  • Cervical Cancer
  • stage III cervical cancer
  • stage IB cervical cancer
  • stage IIB cervical cancer
  • stage IIA cervical cancer
  • stage IVA cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms



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