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Non-Small-Cell Lung CarcinomaPhase 2NCT00271323

Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients

A Phase 2 study testing docetaxel and cisplatin and radiotherapy in people with Non-Small-Cell Lung Carcinoma, run by Sanofi at 1 site in France.

Terminated

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

Official record
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Trial summary

Primary : To determine the safety profile of each treatment group. Secondary : To determine efficacy in term of overall response, disease free survival and survival at 1 and 2 years. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small-Cell Lung Carcinoma
What is being tested?
docetaxel and cisplatin and radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteFrance
Study dates
May 2005to Feb 2007
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent form obtained, signed and dated before specific protocol procedures.
  • Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
  • Patients must have a loco regionally advanced unresectable NSCLC;
  • Stage IIIA with clinical multiple N2 nodes (preferably with histological or cytological confirmation).
  • Patients with peripheral tumours of the lower lobe with contralateral upper mediastinal nodes at station N2 are excluded·
  • Stage IIIB T4 or N3.
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  • In the T4 category, patients with pleural or pericardial effusion and multiple nodules in the same lobe are excluded.
  • Patients with T4 disease secondary to extensive and massive involvement of the great vessels are excluded.Patients should be excluded when the expected risk of pulmonary toxicity is likely to be high, e.g. V20 in excess of 35%.
  • Males or females aged between 18 and 75 years.
  • Life expectancy of at least 12 weeks.
  • WHO performance status 0 or 1.
  • Weight loss <=10% within the last 3 months.
  • Laboratory requirements at entry (within 7 days before randomization):
  • Blood cell counts:
  • Absolute neutrophils >= 2.0 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Hemoglobin >= 10 g/dl
  • Renal function:
  • Serum creatinine <=1 x the upper limit of normal (UNL). In case of borderline value of serum creatinine, the 24h creatinine clearance should be >= 60 mL/min.
  • Hepatic function:
  • Serum bilirubin <= 1 x UNL
  • ASAT and ALAT <= 2.5 x UNL
  • Alkaline phosphatase <= 5 x UNL Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase> 2.5 x UNL are not eligible for the study.
  • Lung function tests at entry:
  • FEV1: >= 50 % x Normal value
  • DLCO: >= 50 % x Normal value
  • Adequate cardiac function.
  • Patient with either measurable and/or non-measurable lesion (according to RECIST criteria).

Who cannot join

  • Diagnosis of small cell lung cancer.
  • Pregnant or lactating women.
  • Patients (male or female) with reproductive potential not implementing adequate contraceptive measures.
  • Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC.
  • Prior surgery for NSCLC, if less than 5 years from study.
  • Prior radiotherapy for NSCLC.
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  • History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
  • Symptomatic peripheral neuropathy Grade >= 2 except if due to trauma.
  • Other serious concomitant illness or medical conditions:
  • Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias.
  • History of significant neurological or psychiatric disorders including dementia or seizures.
  • Active infection requiring IV antibiotics.
  • Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy.
  • Superior vena cava syndrome contra-indicating hydration.
  • Preexisting pericardial effusion.
  • Preexisting symptomatic pleural effusion.
  • Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
  • Distant metastasis.
  • Concurrent treatment with any other experimental anti-cancer drugs.
  • Concomitant or within 4-week period administration of any other experimental drug under investigation.
  • Significant ophthalmologic abnormalities.
  • Moderate to severe dermatitis.
  • Hypersensitivity to docetaxel, cisplatin, or any of its excipients.
  • Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and not likely to complete the study.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Sanofi-Aventis

    Paris

Other trials in France

About this study

Official title: A Two Arm Phase II Study Assessing Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-multiple cN2 or IIIB)

  • Primary : To determine the safety profile of each treatment group.
  • Secondary : To determine efficacy in term of overall response, disease free survival and survival at 1 and 2 years.
Being tested
docetaxel and cisplatin, radiotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • docetaxel and cisplatinDrug

    Docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemo-radiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy.

  • radiotherapyRadiation

    Docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.

Study groups in NCT00271323
Study groupRoleWhat they receive
1ExperimentalInduction chemotherapy followed by concurrent chemoradiotherapy
Receives: Drug: docetaxel and cisplatin
2Active comparatorConcurrent chemo-radiotherapy followed by consolidation chemotherapy
Receives: Radiation: radiotherapy

What is being measured

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

  1. overall response rate

    Measured: in population of patients eligible and evaluable for response

  2. time to progression

    Measured: from the date of start treatment until progression

  3. duration of response

    Measured: only on responders

Timeline

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

  1. First posted30 Dec 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionFeb 2007
  4. Study completionFeb 2007

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00271323
Sponsor's protocol ID
XRP6976B_2507
Other IDs
EudraCT #: 2005-001276-12
Status last verified
Dec 2009
First submitted
29 Dec 2005
Last updated
23 Dec 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel and cisplatin and radiotherapy in people with Non-Small-Cell Lung Carcinoma, run by Sanofi at 1 site in France.

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 28 inclusion and 27 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 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

The study was stopped early. 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 (time frame: in population of patients eligible and evaluable for response). The study lists 3 primary outcomes in all. 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 NCT00271323.

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 23 Dec 2009.

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