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

NCT00152828 | Completed Phase 1 DMC

• 2 other identifiers: UHN REB 00-0431-CNational Cancer Instit.Canada
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy

  1 year

Secondary Outcomes (2)

• Objective changes in tumour oxygenation and IFP

  1 year

• Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis)

  1 year

Study Arms (1)

Celecoxib

EXPERIMENTAL

Celecoxib

Drug: Celecoxib

Interventions

Celecoxib DRUG

Celecoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anthony Fyles, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: February 1, 2001
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

CA (1)