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Ovarian NeoplasmsPhase 2carbo-cox2NCT01124435

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

A Phase 2 study testing Carboplatin plus Celecoxib in people with Ovarian Neoplasms, run by Catholic University of the Sacred Heart at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
Carboplatin plus Celecoxib
How many people
45 participants
Where
1 siteItaly
Study dates
Oct 2003to Dec 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Rome, Italy, 00168

Other trials in Italy

About this study

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

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.

Read the 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

Being tested
Carboplatin plus Celecoxib
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
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carboplatin plus CelecoxibDrug

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48 months

Secondary outcomes (1)

  1. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2010 (estimated)
  2. Study startOct 2003
  3. Primary completionSep 2007
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01124435
Sponsor's protocol ID
935/03
Acronym
carbo-cox2
Status last verified
Dec 2008
First submitted
14 May 2010
Last updated
4 Jun 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12181243

  • 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.

    PubMed 21627839

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin plus Celecoxib in people with Ovarian Neoplasms, run by Catholic University of the Sacred Heart at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of the Combination Carboplatin plus Celecoxib in Heavily Pre-treated Recurrent Ovarian Cancer Patients (time frame: 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01124435, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2010.

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