Celebrex - Cervix: Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix

Cervix Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152828
• Other study ID #: UHN REB 00-0431-C
• Secondary ID: National Cancer
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 7, 2005
• Last updated: February 8, 2016
• Start date: February 2001
• Est. completion date: January 2011

Study information

• Verified date: February 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This is a phase I/II study to evaluate the safety and toxicity of celecoxib in combination with standard concurrent cisplatin and radiotherapy in women with locally advanced cervix cancer. In addition, we aim to determine the effect of celecoxib (Celebrex) on tumour oxygenation, interstitial fluid pressure, COX-2 levels, prostaglandin E2 levels, angiogenesis and apoptosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cervix Neoplasms
• Uterine Cervical Neoplasms

Intervention

Drug:
• Celecoxib

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Cancer Trials Group, Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy		1 year	No
Secondary	Objective changes in tumour oxygenation and IFP		1 year	No
Secondary	Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis)		1 year	No