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Carcinoma, Non-Small-Cell LungPhase 2NCT00905983

Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly 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 11 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in Western countries. Standard treatment for patients with good performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly… Read more about this study

Who is it for?
Ages 70 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
48 participants
Where
11 sitesSpain
Study dates
Oct 2007to Sep 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 70 years and older
  • All sexes
  • No healthy volunteers
  • 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 are 70 years old.
  • Patients with 1 > ECOG PS =1.
  • Patients must have at least one measurable lesion, no previously irradiated.
  • Life expectancy of at least 12 weeks.
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  • Adequate organ function according to the following criteria:
  • Bone marrow: ANC >= 2.0x10(9)cells/L; Platelet count >= 100x10(9)cells/L; Leukocyte count >= 4000x10(6)/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.
  • 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 to study drugs.
  • Concurrent treatment with other experimental drugs.
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  • 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

11 sites in 1 country.

11 sites in 1 country

Spain11 sites

  • Hospital Virgen de los Lirios

    Alcoy, Alicante, 3804

  • Hospital San Juan de Alicante

    Alicante, Alicante, 03550

  • Hospital Clínica de Benidorm

    Benidorm, Alicante, 03501

  • Hospital Provincial de Castellón

    Castellon, Castellón, 12002

  • Hospital General de Elda

    Elda, Alicante, 03600

  • Hospital Althaia, Xarxa Asistencial de Manresa

    Manresa, Barcelona, 08243

  • Hospital de Sagunto

    Sagunto, Valencia, 46520

  • Hospital Universitario La Fe

    Valencia, Valencia, 46009

  • Instituto Valenciano de Oncología

    Valencia, Valencia, 46009

  • Hospital Arnau de Vilanova

    Valencia, Valencia, 46015

  • Hospital Universitario Dr. Peset

    Valencia, Valencia, 46017

Other trials in Spain

About this study

Official title: Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.

Lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in Western countries. Standard treatment for patients with good performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to platinum related toxicities. Several drugs with novel mechanisms of action and significant activity in NSCLC have been developed; including docetaxel and gemcitabine that are also active in patients previously treated with cisplatin-based regimens and have a more favorable toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports its use as first-line chemotherapy, especially in patients with severe comorbidities as elderly patients. To improve the therapeutic index of this combination, the investigators performed a study with biweekly gemcitabine and docetaxel in elderly patients.

Being tested
Gemcitabine and Docetaxel
Keywords
Carcinoma, Non-Small-Cell, Elderly patients, Docetaxel, Gemcitabine
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Carcinoma

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 groups in NCT00905983
Study groupRoleWhat they receive
Gemcitabine and DocetaxelExperimentalPatients 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.

  1. Overall response rate = sum of complete and partial tumour responses divided by the number of included patients

    Measured: 2 & 4 months

Secondary outcomes (5)

  1. Overall survival

    Measured: time from study entry to death from any cause

  2. Toxicity

    Measured: biweekly

  3. Duration of response

    Measured: time from first response (CR or PR) to tumor progression

  4. Time to progression

    Measured: time from study entry to observed tumor progression or death due to progression disease

  5. 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.

  1. First posted21 May 2009 (estimated)
  2. Study startOct 2007
  3. Primary completionSep 2009 (estimated)
  4. Study completionSep 2011 (estimated)

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00905983
Sponsor's protocol ID
CPNM-ANC-07
Status last verified
May 2009
First submitted
19 May 2009
Last updated
21 May 2009
Results posted
No
Data monitoring committee
No

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 11 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 10 inclusion and 9 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 11 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?

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?

Overall response rate = sum of complete and partial tumour responses divided by the number of included patients (time frame: 2 & 4 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 NCT00905983.

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.

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