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

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT00152828
• Collaborator: NCIC Clinical Trials Group (Other), Princess Margaret Hospital, Canada (Other)
• Enrollment: 31
• Location: 1
• Arm: 1
• Duration (Months): 119
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervix Neoplasms	Drug: Celecoxib	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2001
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Celecoxib Celecoxib	Drug: Celecoxib

Outcome Measures

Primary Outcome Measures

1. Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy [1 year]

Secondary Outcome Measures

1. Objective changes in tumour oxygenation and IFP [1 year]

2. Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis) [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

• University Health Network, Toronto
• NCIC Clinical Trials Group
• Princess Margaret Hospital, Canada

Investigators

• Principal Investigator: Anthony Fyles, MD, Princess Margaret Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT00152828
• Other Study ID Numbers: UHN REB 00-0431-C; National Cancer Instit.Canada
• First Posted: Sep 9, 2005
• Last Update Posted: Feb 9, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Celecoxib

Study Results

No Results Posted as of Feb 9, 2016