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Advanced Non-Small Cell Lung CancerPhase 3DISTAL-2NCT00345059

The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer

A Phase 3 study testing docetaxel, vinorelbine and gemcitabine in people with Advanced Non-Small Cell Lung Cancer, run by National Cancer Institute, Naples at 24 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine. Read more about this study

Who is it for?
Ages Up to 75 years
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
docetaxel, vinorelbine and gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
24 sitesItaly
Study dates
May 2005to May 2008
Phase
Phase 3
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 Up to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Written informed consent
  • Age > 18
  • Histological diagnosis of non small-cell lung cancer (NSCLC)
  • Stage IIIb or Stage IV disease (in IIIb, previous treatment with chemotherapy + radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion)
  • Disease in progression
  • Previous chemotherapy with platinum-derivative (and with > 21 days from last administration)

Who cannot join

  • ECOG performance status > 2
  • Age > 75 years
  • History of malignant neoplasm within the previous 5 years (except for baso- or spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
  • Previous treatment with docetaxel
  • Presence of symptomatic cerebral metastasis
  • Neutrophils < 2.0 x 109/l, platelets < 100,000/l, hemoglobin > 10g/dl
Show all 12Show fewer
  • Bilirubin < 1.5 x the upper normal limit
  • SGOT , SGPT, or bilirubin > 1.25 x the upper normal limits except in the presence of hepatic metastasis
  • Creatinine >1.25 x the upper normal limit
  • Any concomitant pathology that would, in the Investigator's opinion, contraindicate the use of the drugs in the protocol
  • Inability to comply with follow up
  • Pregnant or nursing females

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Italy24 sites

  • Presidio Ospedaliaro Alto Gardo e Ledro

    Arco, TN, 38062

  • Ospedale Fatebenefratelli, U.O. di Oncologia

    Benevento, BN, 82100

  • Azienda Ospedaliera G. Rummo

    Benevento, BN

  • Università di Chieti

    Chieti, CH, 66013

  • U.L.S.S. 15 Regione Veneto

    Cittadella, PD

  • Div. di Medicina Generale Osp. dei SS. Benedetto e Geltrude -Presidio Osp. Di Cuggiono - Az. Osp. Di Legnano

    Cuggiono, MI

  • Ospedali Riuniti

    Foggia, FG

  • Ospedale Umberto di Frosinone

    Frosinone, FR, 03031

  • Ospedale di Gaeta

    Gaeta, LT, 04024

  • Ospedale Civile di Legnano

    Legnano, MI

  • Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia

    Mantua, MN, 46100

  • Ospedale S. Paolo

    Milan, MI, 20142

  • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica

    Monteforte Irpino, AV, 83024

  • Ospedale S. Gerado

    Monza, MI, 20052

  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

    Naples, 80131

  • Divisione di Oncologia Medica, U.S.L.L. 13

    Noale, VE, 30033

  • Istituto Oncologico Veneto

    Padova, PD

  • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico

    Palermo, PA, 90146

  • Azienda Ospedaliera V. Cervello

    Palermo, PA

  • Ospedale Buccheri La Ferla - Fatebenefratelli

    Palermo, PA

  • Azienda Ospedaliera Di Busto Arsizio

    Saronno, VA, 21047

  • Azienda Ospedaliera Giovanni Paolo II

    Sciacca, AG

  • Azienda Ospedaliera Universitaria Senese

    Siena, SI, 53100

  • Ospedale E. Morelli

    Sondalo, SO, 23039

Other trials in Italy

About this study

Official title: Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer

The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.

Read the detailed description

This study is for patients with previously diagnosed advanced non small cell lung cancer (NSCLC, stage IIIb or IV) who had progression of their disease during or after first-line therapy containing platinum. Patients will be assigned to receive 6 cycles of therapy from one of four treatment regimens:

  • docetaxel
  • docetaxel + vinorelbine
  • docetaxel + gemcitabine
  • docetaxel + capecitabine
Keywords
second line, monochemotherapy, combination chemotherapy, platinum refractory, previously treated

What participants receive

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

Study groups in NCT00345059
Study groupRoleWhat they receive
docetaxelActive comparatorsingle agent docetaxel
Receives: Drug: docetaxel
docetaxel + vinorelbine OR gemcitabineExperimentaldocetaxel in combination with either vinorelbine or with gemcitabine
Receives: Drug: docetaxel; Drug: vinorelbine; Drug: gemcitabine
docetaxel + capecitabineExperimentaldocetaxel in combination with capecitabine
Receives: Drug: docetaxel; Drug: capecitabine

What is being measured

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

  1. overall survival

    Measured: one year

Timeline

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

  1. First posted27 Jun 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionMay 2008
  4. Study completionMay 2008

Why it stopped: slow accrual

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00345059
Sponsor's protocol ID
DISTAL-2
Acronym
DISTAL-2
Status last verified
Jan 2016
First submitted
26 Jun 2006
Last updated
14 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • Gebbia V, Morena R, Frontini L, Aitini E, Daniele B, Gamucci T, Di Maio M, Morabito A, Gallo C, Gridelli C. The DISTAL-2 phase III randomized trial of single agent weekly docetaxel (wD) vs wD plus gemcitabine (G) or vinorelbine (V) vs wD plus capecitabine (X) as second-line treatment of advanced non-small-cell lung cancer (NSCLC) patients (pts). J Clin Oncol 26: 2008 (May 20 suppl; abstr 19057)

  • Gebbia V, Gridelli C, Verusio C, Frontini L, Aitini E, Daniele B, Gamucci T, Mancuso G, Di Maio M, Gallo C, Perrone F, Morabito A. Weekly docetaxel vs. docetaxel-based combination chemotherapy as second-line treatment of advanced non-small-cell lung cancer patients. The DISTAL-2 randomized trial. Lung Cancer. 2009 Feb;63(2):251-8. doi: 10.1016/j.lungcan.2008.05.027. Epub 2008 Jul 15.

    PubMed 18632181

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing docetaxel, vinorelbine and gemcitabine in people with Advanced Non-Small Cell Lung Cancer, run by National Cancer Institute, Naples at 24 sites 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: slow accrual). 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 survival (time frame: one year). 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 NCT00345059, 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 14 Jan 2016.

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