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

NCT ID: NCT00152828

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2011-01-31

Brief 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.

Conditions

Cervix Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Celecoxib

Celecoxib

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

Interventions

Celecoxib

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Fyles, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

National Cancer Instit.Canada

Identifier Type: -

Identifier Source: secondary_id

UHN REB 00-0431-C

Identifier Type: -

Identifier Source: org_study_id