Study of the Combination Carboplatin Plus Celecoxib in Heavily Pre-treated Recurrent Ovarian Cancer Patients

NCT01124435 | Completed Phase 2 DMC

• 1 other identifier: 935/03
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the antitumor activity and potential adverse effects of the combination celecoxib plus carboplatin in patients with recurrent, heavily pre-treated Ovarian Cancer (OC). The potential changes induced by the experimental combination on angiogenesis-related serum markers and quality of life measures will be also evaluated.The main objective is to evaluate the response rate. Secondary objectives are the following:toxicity;progression free survival;overall survival;duration of response;quality of life;modulation of angiogenesis-related molecules.

Conditions

Ovarian Neoplasms

Keywords

Carboplatin plus Celecoxib; Pre-treated Recurrent Ovarian Cancer Patients; The antitumor activity and potential adverse effects; tumor response rate; toxicity; progression free survival; duration of response; quality of life

Outcome Measures

Primary Outcomes (1)

• Efficacy of the Combination Carboplatin plus Celecoxib in Heavily Pre-treated Recurrent Ovarian Cancer Patients

  The tumor response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and duration of response, progression-free survival (PFS), overall survival (OS), toxicity assessment, and quality of life (QoL) measures with carboplatin-celcoxib in heavly pretreated recurrent ovarian cancer patients.

  48 months

Secondary Outcomes (1)

• The modulation of angiogenesis-related molecules with the combination celecoxib plus carboplatin in patients with recurrent, heavily pre-treated OC

  12 months

Interventions

Carboplatin plus Celecoxib DRUG

celecoxib (200 mg tablets by mouth twice daily, day 1 to 28), associated to intravenous carboplatin (area under the curve (AUC) 5 over 30 to 60 minutes, every 28 days).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent epithelial ovarian or fallopian tube or peritoneal serous carcinomas with measurable disease as assessed by Response Evaluation Criteria in Solid Tumors criteria
• Patients will require to have received a platinum-containing regimen as primary treatment and at least one line of chemotherapy for recurrent disease
• An interval time from the last platinum-based chemotherapy after 6months
• years of years
• Eastern Cooperative Oncology Group performance status of 0 to 2
• Adequate bone marrow
• Adequate renal and hepatic functions
• Written informed consent to the study protocol

You may not qualify if:

• Hypersensitivity to celecoxib or aspirin or other nonsteroidal anti-inflammatory drugs or sulfonamides
• Significant comorbidities including any active coronary artery disease requiring management or symptomatic congestive heart failure or bleeding diathesis or uncontrolled severe hypertension or active gastrointestinal ulcer within 12 months or chronic inflammatory bowel diseases or deep venous or arterial thrombosis within 12 months or history of pulmonary embolism
• Concomitant use of possible interactive drugs
• Surgery and chemotherapy or radiotherapy within 1 month
• Actual or potential childbearing
• Breast-feeding
• Prior cancer treatment with a COX2 inhibitor
• Any psychological and/or sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Department of Obstetrics and Gynecology,Catholic University, Rome, Italy

Rome, Italy, 00168, Italy

Location

Related Publications (2)

• Ferrandina G, Lauriola L, Zannoni GF, Fagotti A, Fanfani F, Legge F, Maggiano N, Gessi M, Mancuso S, Ranelletti FO, Scambia G. Increased cyclooxygenase-2 (COX-2) expression is associated with chemotherapy resistance and outcome in ovarian cancer patients. Ann Oncol. 2002 Aug;13(8):1205-11. doi: 10.1093/annonc/mdf207.

  PMID: 12181243 RESULT

• Legge F, Paglia A, D'Asta M, Fuoco G, Scambia G, Ferrandina G. Phase II study of the combination carboplatin plus celecoxib in heavily pre-treated recurrent ovarian cancer patients. BMC Cancer. 2011 May 31;11:214. doi: 10.1186/1471-2407-11-214.

  PMID: 21627839 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin; Celecoxib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Giovanni sCAMBIA, PhD

  Department of Obstetrics and Gynecology,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 17, 2010
• Study Start: October 1, 2003
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2008
• Last Updated: June 4, 2010

Record last verified: 2008-12

Locations

IT (1)