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A randomized placebo-controlled phase II/III with celecoxib in patients with locally advanced or metastatic non-small cell lung cancer.


- candidate number5434
- NTR NumberNTR1703
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mrt-2009
- Secondary IDs2003/086 METC UMC Maastricht
- Public TitleA randomized placebo-controlled phase II/III with celecoxib in patients with locally advanced or metastatic non-small cell lung cancer.
- Scientific TitleA randomized placebo-controlled phase II/III with celecoxib in patients with locally advanced or metastatic non-small cell lung cancer.
- ACRONYMNVALT-4 study
- hypothesisIs the effect of addition of the COX-2 inhibitor celecoxib to docetaxel/carboplatin chemotherapy inducing a tumour response or/and is slowing the progression.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC)
- Inclusion criteria1. Histological or cytological diagnosis of unresectable (stage III-b with or without pleuritis carcinomatosa) or disseminated (stage IV) NSCLC;
2. Age ≥ 18 years;
3. No prior chemotherapeutic treatment for NSCLC;
4. Measurable tumour on physical examination, chest X-ray, CT-scan;
5. Performance status 0-2 (WHO-score, see appendix II);
6. Prior radiotherapy is allowed as long as: No more than 25% of red bone marrow was irradiated;
7. The irradiated area is not the only source of measurable disease;
8. Estimated life expectancy of at least 12 weeks;
9. Adequate bone marrow reserve: leukocytes ≥ 3,0 x109/L, neutrophils ≥ 1,5 x109/L, platelets 100 .≥ x109/L, and hemoglobin ≥ 6,2 mmol/L;
10. Adequate renal function (serum creatinine ≤ 130 mol/L or creatinine clearance ≥ 60 ml/min);
11. Adequate liver function (total bilirubin ≤ UNL, ALAT/SGPT and ASAT/SGOT ≤ 2,0 x UNL, alkaline phosphatase ≤ 5,0 x UNL for the institution (UNL = Upper Normal Limit);
12. Patients of childbearing age should take medically approved contraceptive precautions during the trial and 3 months afterwards;
13. The subject is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors. Chronic use of NSAIDs is defined as a frequency of 7 consecutive days (1 week) for >3 weeks per year or more than 21 days throughout the year;
14. The use of cardioprotective dosages acetyl salicylic acid < 150 mg/day is allowed;
15. Patients must be able to comply with the scheduled visits;
16. Patients must give written informed consent before starting the study.
- Exclusion criteria1. Other serious diseases, such as congestive heart failure NYHA class II-IV, established ischaemic heart disease or cerebrovascular disease, myocardial infarction within the last 12 months, peripheral arterial disease, uncontrolled hypertension, active peptic ulcer, active gastrointestinal bleeding, active infection or significant psychiatric illness;
2. Symptomatic brain metastases;
3. Patients with uncorrected hypercalcemia;
4. Patients with peripheral polyneuropathy grade ≥ 2 CTC Criteria;
5. Patients with a second primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell carcinomas of the skin or adequately treated upper respiratory tract malignancies, disease-free more than 1 year after treatment;
6. ASAT and ALAT > 1,5 x UNL and alkaline phosphatase > 2,5 x UNL;
7. Patients who are pregnant or breast-feeding;
8. Known hypersensitivity or intolerance for NSAIDs, acetyl salicylic acid or olphonamides;
9. Participation in another trial with an investigational drug.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2003
- planned closingdate31-mrt-2008
- Target number of participants540
- InterventionsTreatment Group A:
Docetaxel 75 mg/m plus carboplatin (AUC = 6), on Day 1 every 21 days for 5 cycles. Placebo 2 x dd 400 mg, starting on Day 1 to a maximum of 3 years.
Placebo starts simultaneously with docetaxel/carboplatin chemotherapy.

Treatment Group B:
Docetaxel 75 mg/m plus carboplatin (AUC = 6), on Day 1 every 21 days for 5 cycles. Celecoxib 2 x dd 400 mg, starting on Day 1 to a maximum of 3 years.
Celecoxib starts simultaneously with docetaxel/carboplatin chemotherapy.
- Primary outcomePhase II:
To evaluate the antitumoral efficacy of celecoxib in combination with docetaxel/carboplatin in terms of tumour response (CR, PR versus SD, PD).

Phase III:
To assess Overall Survival (OS).
- Secondary outcomePhase II:
1. To evaluate safety and tolerability of docetaxel/carboplatin with celecoxib as compared with docetaxel/carboplatin and placebo;
2. To assess Quality of Life as measured by EORTC QLQ-C30 and QLQ-LC13;
3. To estimate Progression-Free Survival (PFS);
4. To assess Overall Survival (OS).

Phase III:
1. To evaluate safety and tolerability of docetaxel/carboplatin with celecoxib as compared with docetaxel/carboplatin and placebo;
2. To assess Quality of Life as measured by EORTC QLQ-C30 and QLQ-LC13;
3. To assess Time To Progression (TTP).
- TimepointsThe planned duration of the enrolment (i.e. first patient randomized to last patient randomized) is 12 months for the phase II study and an additional 30 months for the phase III study.
- Trial web sitehttp://www.nvalt-oncology.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD, PhD M.M.H. Hochstenbag
- CONTACT for SCIENTIFIC QUERIESMD, PhD M.M.H. Hochstenbag
- Sponsor/Initiator University Hospital Maastricht (AZM), Department of Pulmonology
- Funding
(Source(s) of Monetary or Material Support)
Ortho Biotech, Aventis Pharma, The Netherlands, Pfizer B.V., KWF Kankerbestrijding
- PublicationsN/A
- Brief summaryIn this study the effect of the addition of celecoxib to docetaxel/carboplatin chemotherapy in patients with advanced non-small cell lung cancer were evaluated. The proposed mechanisms of action of celecoxib is inhibition of tumour angiogenesis, induction of apoptosis and reduction of cell proliferation. In this randomized placebo-controlled study we first started as a phase 2 study to evaluate toxicity. In the first 142 patients no additional toxicity was observed. Therefore we continued with the fase 3 part and included a total of 561 patients (21 patients more than planned because of an estimated drop-out rate). After the study a full report on safety and efficay will be presented.
- Main changes (audit trail)
- RECORD9-mrt-2009 - 14-sep-2009


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