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A Phase I/II Trial of the Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervix Neoplasms

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Trial Information

A Phase I/II Trial of the Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix


Inclusion Criteria:



- Biopsy-proven carcinoma of the cervix, with visible/palpable tumours; FIGO stage
T1B-3B, NO/1, MO, to be treated with definitive radiotherapy and chemotherapy

- ECOG performance status of 0, 1, or 2

- Adequate hematologic function; Granulocyte count greater than 1.5 x 109/L, Platelet
count greater than 100 x 109/L

- Adequate organ function; Serum creatinine £ 1.25 x ULN, or a calculated creatinine
clearance ³ 50 mL/min, Serum bilirubin £ 1.25 x ULN and AST/ALT £ 3xULN

- No prior treatment for cervix cancer

- Informed consent

Exclusion Criteria:

- Use of an NSAID in the 2 weeks prior to study enrollment

- Patients with an active malignancy at another site

- Patients with significant cardiac, renal, or pulmonary disease or any other medical
conditions that may preclude radical therapy

- Patients who have significant history of ischaemic heart disease or stroke who would
be deemed not suitable for cessation of their daily prophylactic aspirin

- Patients with history of peptic ulcer disease or previous NSAID related
gastrointestinal bleeding

- Patients with hypersensitivity to NSAIDS or celecoxib, or sulfonamides

- Patients who unwilling or unable to give informed consent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy

Principal Investigator

Anthony Fyles, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 00-0431-C

NCT ID:

NCT00152828

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Cervix Neoplasms
  • Neoplasms
  • Uterine Cervical Neoplasms

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