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Non-Small-Cell Lung CancerPhase 2NCT00705549

Individualized Therapy Based of Tumoral mRNA Levels of ERCC1, RRM1 and BRCA1 in Advanced Non-Small-Cell Lung Cancer

A Phase 2 study testing Gemcitabine, Cisplatin and Docetaxel in people with Non-Small-Cell Lung Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.

Terminated

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

Official record
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Trial summary

This is a prospective pilot phase II trial, in patients with wet stage IIIb and IV NSCLC using chemotherapy regimens which will be defined according to the pharmacogenomic profile (tumoral expression of ERCC1, BRCA1 and RRM1) of the tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small-Cell Lung Cancer
What is being tested?
Gemcitabine, Cisplatin and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
9 sitesGreece
Study dates
Feb 2008to 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically proven Stage IV and Stage III (with malignant pleural or pericardial effusion) squamous or adenocarcinoma carcinomas of the lung
  • Adequate Formalin Fixed Paraffin Embedded tumor sample provided for molecular analysis
  • No previous anticancer treatment for metastatic/advanced disease. Patients who received prior adjuvant chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy.
  • Age above 18 years
  • Performance status (ECOG) 0-2
  • Life expectancy >= 3 months
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  • Effective contraception for both male and female subjects if the risk of conception exists
  • Adequate hematologic parameters (absolute neutrophil count >= 1.5x109/L and platelets >= 100x109/L), creatinine (GFR>= 60ml/min) and total bilirubin < 1.5 times the upper limit of normal; aspartate and alanine aminotransferase < 2,5 times the upper limit of normal
  • All patients will have to sign written informed consent in order to participate in the study

Who cannot join

  • Patients with non-squamous tumors who have no contradiction for administration of bevacizumab
  • Active infection or malnutrition (loss of more than 20% of the body weight)
  • Known hypersensitivity reaction to any of the component of the treatment
  • Concurrent or previous chronic systemic immune therapy
  • Pregnancy (absence to be confirmed by ß-HCG test) or lactation period
  • Known alcohol/drug abuse
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  • Legal incapacity or limited legal capacity
  • Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
  • A second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma
  • Previous radiotherapy to the target lesions. Patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields
  • Patients with severe cardiac dysfunction, unstable angina petrosis, or high risk of uncontrolled arrhythmia

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Greece9 sites

  • University General Hospital of Alexandroupolis, Dept. of Medical Oncology

    Alexandroupoli

  • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

    Athens

  • 401 Military Hospital, Medical Oncology Unit

    Athens

  • Air Forces Military Hospital, Dep of Medical Oncology

    Athens

  • IASO" General Hospital of Athens, 1st Dep of Medical Oncology

    Athens

  • Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

    Athens

  • Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases

    Athens

  • "Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

    Piraeus

  • "Theagenion" Anticancer Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

About this study

Official title: Feasibility and Efficacy of Molecular Analysis-Directed Individualized Therapy Based of Tumoral mRNA Levels of ERCC1, RRM1 and BRCA1 in Advanced Non-Small-Cell Lung Cancer

This is a prospective pilot phase II trial, in patients with wet stage IIIb and IV NSCLC using chemotherapy regimens which will be defined according to the pharmacogenomic profile (tumoral expression of ERCC1, BRCA1 and RRM1) of the tumor cells.

Read the detailed description

Advanced stage NSCLC is essentially a fatal disease and treatment is mainly palliative. Systemic cisplatin-based chemotherapy remains the mainstream for the treatment of advanced non-small cell lung cancer (NSCLC) since it improves survival, symptom control and quality of life compared to best supportive care.

The selection of appropriate treatment for individual patients remains a challenge in clinical oncology, particularly in the advanced disease. Several lines of evidence indicate that polymorphisms, gene transcripts and gene mutations can play a predictive role and can be used to tailor chemotherapy in different subgroups of cancer patients. There are evidence lead us to use the expression levels of ERCC1 by the tumor as a molecular marker for customized chemotherapy. Another gene, the BRCA1 has a crucial role in DNA repair, since it is implicated in transcription-coupled nucleotide excision repair (TC-NER), leading to radio- and chemo-resistance. RRM1,localized in 11p15.5,also acts as a putative tumor suppressor gene. RRM1 overexpression was related to gemcitabine resistance in human oropharyngeal epidermoid carcinoma KB cells as well as in patients with NSCLC. For those reason we decided to conduct a prospective pilot phase II trial, in patients with wet stage IIIb and IV NSCLC using chemotherapy regimens which will be defined according to the pharmacogenomic profile (tumoral expression of ERCC1, BRCA1 and RRM1) of the tumor cells.

Being tested
Gemcitabine, Cisplatin, Docetaxel, Vinorelbine, Pemetrexate
Keywords
Advanced, NSCLC, ERCC1, RRM1, BCRA1, Alimta, Gemcitabine
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.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine I.V at the dose of 1000mg/m2 on Day 1 and Day 8

  • CisplatinDrug

    Also called CDDP

    Cisplatin I.V at the dose of 75mg/m2 on Day 1

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel I.V at the dose of 75mg/m2 on Day 1

  • CisplatinDrug

    Also called CDDP

    Cisplatin I.V at the dose of 80mg/m2 on Day 1

  • VinorelbineDrug

    Also called Navelbine

    Vinorelbine per os 50mg every Monday, Wednesday and Friday

  • PemetrexateDrug

    Also called Alimta

    Pemetrexate I.V 500mg/m2 on Day 1

Study groups in NCT00705549
Study groupRoleWhat they receive
1ExperimentalGemzar/Cisplatin
Receives: Drug: Gemcitabine; Drug: Cisplatin
2ExperimentalTaxotere/Cisplatin
Receives: Drug: Cisplatin; Drug: Docetaxel
3ExperimentalCisplatin/Navelbine metronomic
Receives: Drug: Cisplatin; Drug: Vinorelbine
4ExperimentalTaxotere/Gemzar
Receives: Drug: Gemcitabine; Drug: Docetaxel
5ExperimentalGemzar
Receives: Drug: Gemcitabine
6ExperimentalTaxotere
Receives: Drug: Docetaxel
7ExperimentalNavelbine metronomic
Receives: Drug: Vinorelbine
8ExperimentalAlimta/Cisplatin
Receives: Drug: Cisplatin; Drug: Pemetrexate
9ExperimentalAlimta/Gemzar
Receives: Drug: Gemcitabine; Drug: Pemetrexate
10ExperimentalTaxotere
Receives: Drug: Docetaxel
11ExperimentalAlimta
Receives: Drug: Pemetrexate

What is being measured

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

  1. Objective Response Rate (ORR) based on the pharmacogenomic profile of the ERCC1, RRM1 and BRCA1 expression

    Measured: Objective responses confirmed by CT or MRI

Secondary outcomes (4)

  1. Determine the incidence of the different pharmacogenomic profiles as defined by the combined expression of ERCC1, RRM1 and BCRA1

    Measured: Comparison of molecular determinants for response in the primary tumor and peripheral blood (ERCC1 polymorphism ,TXR1 and TSP1 mRNA expression by Q-RT-PCR, Molecular markers related to responsiveness to Alimta )

  2. Time to Tumor Progression

    Measured: 1 year

  3. Overall Survival

    Measured: 1 year

  4. Toxicity

    Measured: Toxicity assessment on each chemotherapy cycles

Timeline

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

  1. First posted26 Jun 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionSep 2011
  4. Study completionSep 2011

Why it stopped: Due to poor 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00705549
Sponsor's protocol ID
CT/07.23
Status last verified
Feb 2013
First submitted
25 Jun 2008
Last updated
13 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Cisplatin and Docetaxel in people with Non-Small-Cell Lung Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.

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: stopped early, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Greece. 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 (reason given: Due to poor 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?

Objective Response Rate (ORR) based on the pharmacogenomic profile of the ERCC1, RRM1 and BRCA1 expression (time frame: Objective responses confirmed by CT or MRI). 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 NCT00705549.

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 13 Feb 2013.

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