No registrations found.
ID
Source
Brief title
Health condition
Niet-kleincellig longcarcinoom (NSCLC).
Sponsors and support
Department of Pulmonology
Aventis Pharma BV, Nederland
Orhtobiotec, Nederland
Pfizer Nederland
Intervention
Outcome measures
Primary outcome
Phase 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 outcome
Phase 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).
Background summary
In 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.
Study objective
Is the effect of addition of the COX-2 inhibitor celecoxib to docetaxel/carboplatin chemotherapy inducing a tumour response or/and is slowing the progression.
Study design
The 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.
Intervention
Treatment Group A:
Docetaxel 75 mg/m² 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/m² 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.
University Medical Center Maastricht
Department of Pulmonology
P Debyelaan 25
Maastricht 6229 HX
The Netherlands
+31 (0) 433874043
mho@slon.azm.nl
University Medical Center Maastricht
Department of Pulmonology
P Debyelaan 25
Maastricht 6229 HX
The Netherlands
+31 (0) 433874043
mho@slon.azm.nl
Inclusion criteria
1. 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 ¦Ìmol/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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1619 |
| NTR-old | NTR1703 |
| Other | METC UMC Maastricht : 2003/086 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |