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

NCT ID: NCT01124435

Last Updated: 2010-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2008-12-31

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.

Detailed Description

This phase II prospective study will be conducted at the Gynecologic Oncology Units of the Catholic University of Rome and Campobasso, Italy. The study is non-sponsored, investigators initiated. The primary objective is to determine the tumor response rate by RECIST criteria. Secondary objectives included duration of response, progression-free survival (PFS), overall survival (OS), toxicity assessment, and QoL measures.Patients are required to take 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). Patients who will develop carboplatin hypersensitivity reaction (HSR) will follow a desensitization protocol, or alternatively will switch to cisplatin. Erythropoietic stimulating agent and myeloid growth factors are not permitted for cycle 1 of study treatment, and their use will be chosen by the treating physician, according to hospital policy.Treatment will be discontinued when any of the following events occurs: radiographic or clinical evidence of cancer progression; deterioration of health or intolerable toxicity; patient refusal. Before starting treatment, patients will be evaluated by medical history, physical examination, cell blood count (CBC), chemistry panel, Ca125, and either computed tomography or magnetic resonance imaging scan. The primary endpoint is to determine the overall response (OR) rate. Secondary endpoints include the assessment of duration of response, PFS, OS, toxicity events and QoL scores. When treatment will be discontinued, patients will receive a follow-up visit every 3 months

Conditions

Ovarian Neoplasms

Study Design

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

Interventions

Carboplatin plus Celecoxib

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• 18 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Catholic University of the Sacred Heart

Principal Investigators

Giovanni sCAMBIA, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology,

Locations

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

Rome, Italy, Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 12181243 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21627839 (View on PubMed)

Other Identifiers

935/03

Identifier Type: -

Identifier Source: org_study_id