Carcinoma, Non-Small-Cell LungPhase 2NCT00906061
Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
A Phase 2 study testing Gemcitabine and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Hospital Arnau de Vilanova at 12 sites in Spain.
Trial summary
There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Gemcitabine and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 12 sitesSpain
- Study dates
- Oct 2007to Oct 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of advanced NSCLC.
- Stage III with pleural effusion and stage IV.
- Patients with ECOG PS 2.
- Patients must have at least one measurable lesion, no previously irradiated.
- Life expectancy of at least 12 weeks.
- Adequate organ function according to the following criteria:
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- Bone marrow: ANC => 2.0x10(9)cells/L; Platelet count => 100x10(9)cells/L; Hemoglobin => 10 g/dL.
- Liver function: Bilirubin <= 1.5 X ULN; Alkaline phosphatase <= 5 x ULN; AST and ALT <= 1.5 x ULN.
- Renal function:serum creatinine <= 2mg/dL.
Who cannot join
- Prior systemic chemotherapy for advanced disease.
- Prior radiotherapy for NSCLC.
- Patients with symptomatic brain metastases.
- No measurable bone metastases or malignant pleural effusion as only measurable lesion.
- History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
- History of hypersensitivity reaction study drugs.
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- Pregnant or lactating women (women of childbearing potential must use adequate contraception).
- Concurrent treatment with other experimental drugs.
- Current peripheral neuropathy NCI grade 2.
- Participation in clinical trials within 30 days of study entry.
- Major surgery, open biopsy or traumatic lesion 28 days before to study start.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites, 12 recruiting
- Recruiting
Hospital Virgen de los Lirios
Alcoy, Alicante, 03804
Francisco Aparisi, Doctor, 0034966528804, joseponcelorenzo@hotmail.com
Francisco Aparisi, Doctor
- Recruiting
Hospital Universitario de Alicante
Alicante, Alicante, 03010
Juan L. Martí, Doctor, 0034965938912, juanluismarti@hotmail.com
Juan L. Martí, Doctor
- Recruiting
Hospital San Juan de Alicante
Alicante, Alicante, 03550
Antonio López, Doctor, 0034965938639, aljimenez73@hotmail.com
Antonio López, Doctor
- Recruiting
Hospital Clínica de Benidorm
Benidorm, Alicante, 03501
Gaspar Esquerdo, Doctor, 0034965853850, gesquerdo@clinicabenidorm.com
Gaspar Esquerdo, Doctor
- Recruiting
Hospital Provincial de Castellón
Castellon, Castellón, 12002
Alfreso Sánchez, Doctor, 0034964354350, asanchezh@seom.org
Alfredo Sánchez, Doctor
- Recruiting
Hospital General de Elda
Elda, Alicante, 03600
Sonia Maciá, Doctor, 0034966989109, smacia@tiscali.es
Sonia Maciá, Doctor
- Recruiting
Hospital Althaia, Xarxa Asistencial de Manresa
Manresa, Barcelona, 08243
Siliva Catot, Doctor, 0034938742112 ext. 3319, scatot@althaia.cat
Silvia Catot, Doctor
- Recruiting
Hospital de Sagunto
Sagunto, Valencia, 46520
Vicente Marco, Doctor, 0034962659405, vginermaco@hotmail.com
Vicente Giner, Doctor
- Recruiting
Hospital Universitario La Fe
Valencia, Valencia, 46009
José Gómez, Doctor, 0034961973138, gcodina@ono.com
José Gómez, Doctor
- Recruiting
Instituto Valenciano de Oncología
Valencia, Valencia, 46009
Miguel A. Muñoz, Doctor, 0034961114013, eclinicos@fivo.org
Miguel A. Muñoz, Doctor
- Recruiting
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
Oscar Juan, Doctor, 0034963868500, juan_osc@gva.es
Oscar Juan, Doctor
- Recruiting
Hospital Universitario Dr. Peset
Valencia, Valencia, 46017
José muñoz, Doctor, 0034961262300, munyoz_joslan@gva.es
José Muñoz, Doctor
About this study
Official title: Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2
There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.
This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.
Read more
In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.
The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Gemcitabine and Docetaxel
- Keywords
- Carcinoma, Small Cell, Lung Neoplasms, Docetaxel, Gemcitabine, ECOG 2
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine and DocetaxelDrug
Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine and Docetaxel | Experimental | Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14. Receives: Drug: Gemcitabine and Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
Measured: 2 and 4 months
Secondary outcomes (5)
Overall survival
Measured: Time from study entry to death from any cause
Toxicity
Measured: Biweekly
Duration of response
Measured: time from first response (CR or PR) to tumor progression
Time to progression
Measured: time from study entry to observed tumor progression or death due to progression disease
Measurement of quality of life
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startOct 2007
- Primary completionOct 2009 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Arnau de Vilanova
- Sponsor type
- University, hospital or other
- Investigators
- Oscar Juan, Doctor, Study director, Hospital Arnau de Vilanova de ValenciaAlfredo Sanchez, Doctor, Principal investigator, Hospital Provincial de CastellónJosé Muñoz, Doctor, Principal investigator, H. Universitario Dr. PesetSonia Maciá, Doctor, Principal investigator, Hospital General de EldaVicente Giner, Doctor, Principal investigator, Hospital de SaguntoJosé Gomez, Doctor, Principal investigator, Hospital Universitario La FeGaspar Esquerdo, Doctor, Principal investigator, Hospital Clínica de BenidormAntonio López, Doctor, Principal investigator, Hospital San Juan de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906061
- Sponsor's protocol ID
- CPNM-PS2-07
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2
- ClinicalTrials.gov ID
- NCT00906061
- Acronym / sponsor ID
- CPNM-PS2-07
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Small Cell, Lung Neoplasms, Docetaxel, Gemcitabine, ECOG 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Hospital Arnau de VilanovaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.
This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.
In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.
The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine and Docetaxel | Experimental | Drug: Gemcitabine and DocetaxelPatients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed diagnosis of advanced NSCLC.
- Stage III with pleural effusion and stage IV.
- Patients with ECOG PS 2.
- Patients must have at least one measurable lesion, no previously irradiated.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (11 listed)
- Prior systemic chemotherapy for advanced disease.
- Prior radiotherapy for NSCLC.
- Patients with symptomatic brain metastases.
- No measurable bone metastases or malignant pleural effusion as only measurable lesion.
- History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine and DocetaxelDocetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6 | Drug | Gemcitabine and Docetaxel |
Primary outcome
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
Time frame: 2 and 4 months
5 secondary outcomes
Overall survival
Time frame: Time from study entry to death from any cause
Toxicity
Time frame: Biweekly
Duration of response
Time frame: time from first response (CR or PR) to tumor progression
Time to progression
Time frame: time from study entry to observed tumor progression or death due to progression disease
Measurement of quality of life
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Juan, Doctor study director
Hospital Arnau de Vilanova de Valencia
Alfredo Sanchez, Doctor principal investigator
Hospital Provincial de Castellón
José Muñoz, Doctor principal investigator
H. Universitario Dr. Peset
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Hospital Arnau de Vilanova at 12 sites in Spain.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oscar Juan, Doctor (0034963868501, juan_osc@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients (time frame: 2 and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2009.