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Study of the Combination Carboplatin Plus Celecoxib in Heavily Pre-treated Recurrent Ovarian Cancer Patients (carbo-cox2)

Primary Purpose

Ovarian Neoplasms

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Carboplatin plus Celecoxib

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Serum levels of vascular endothelial growth factor (VEGF) and endostatin evaluated in a preliminary series of 11 patients at baseline and after 1 month of carboplatin-celecoxib

Full Information

NCT ID

NCT01124435

First Posted

May 14, 2010

Last Updated

June 3, 2010

Sponsor

Catholic University of the Sacred Heart

1. Study Identification

Unique Protocol Identification Number

NCT01124435

Brief Title

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

Acronym

carbo-cox2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Carboplatin plus Celecoxib

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

Time Frame

48 months

Secondary Outcome Measure Information:

Title

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

Description

Serum levels of vascular endothelial growth factor (VEGF) and endostatin evaluated in a preliminary series of 11 patients at baseline and after 1 month of carboplatin-celecoxib

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giovanni sCAMBIA, PhD

Organizational Affiliation

Department of Obstetrics and Gynecology,

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Rome

ZIP/Postal Code

00168

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

12181243

Citation

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.

Results Reference

result

PubMed Identifier

21627839

Citation

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.

Results Reference

derived

Learn more about this trial

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

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