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Carcinoma, Non-Small-Cell LungPhase 2NCT00632203

Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients (Study P05146)

A Phase 2 study testing Temozolomide in people with Carcinoma, Non-Small-Cell Lung and Adenocarcinoma, run by Merck Sharp & Dohme LLC.

Terminated

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

Official record
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Trial summary

The main objective of this study is to investigate whether administration of maintenance temozolomide following standard treatment could possibly prevent or delay the onset of brain metastases in patients with controlled non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Temozolomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
No sites listed yet
Study dates
4 Mar 2008to 7 Jan 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adult subjects (age >=18 years), of either sex, and of any race.
  • Subjects must have stage IV or III with pleural and/or pericardial effusion
  • histologically confirmed NSCLC.
  • Subjects must have completed 2-6 cycles of a standard systemic therapy, with or without radiation therapy, consisting of at least 2 anti-tumor agents as first-line treatment for Stage III/IV disease, and have documented complete response (CR), partial response (PR), or stable disease (SD) per Response Evaluation Criteria in Solid Tumors (RECIST).
  • Response must be confirmed within 4-8 weeks of completing first-line chemotherapy. Study treatment must begin within 12 weeks of completing first-line chemotherapy.
  • Female subjects of childbearing potential or male subjects with female partner of childbearing potential must agree to use a medically accepted method of contraception or be surgically sterilized prior to Screening, while receiving study drug, and for 30 days after stopping study drug. Female subjects of childbearing potential must have a negative pregnancy test confirmed prior to dosing with study drug.
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  • Subjects must be free of any clinically relevant disease (other than stage III/IV NSCLC) that would, in the principal investigator and/or Sponsor's opinion, interfere with the conduct of the study or study evaluations.
  • Subjects must be able to adhere to the dosing and visit schedules, and agree to report medication taken, concomitant medications, and adverse events (AEs).
  • Eastern Cooperative Oncology Group (ECOG) performance status <=2.
  • Clinical laboratory tests (complete blood count [CBC], serum chemistries) must be obtained within 14 days prior to randomization and meet specified criteria.

Who cannot join

  • Brain metastases documented on post-chemotherapy magnetic resonance imaging (MRI).
  • Documented history of brain metastases.
  • Subject has received more than one prior anti-tumor regimen for Stage III/IV disease. "Regimen" refers to single drug or planned combination of two or more anti-tumor therapies. Bevacizumab (Avastin®) as part of a planned sequence of therapy after first-line platinum-containing double regimen is not considered a second regimen. Neo-adjuvant treatment for resectable subjects is not considered a second regimen.
  • Subject has used any investigational product within 4 weeks prior to enrollment.
  • Subject is currently receiving immunotherapy or chemotherapy, cytotoxic or targeted therapy as treatment for active systemic disease. Bevacizumab (Avastin®) as part of the prescribed standard first-line regimen is allowed.
  • Female who is pregnant, or intends to become pregnant, during the study.
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  • Subject is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
  • Subject is currently participating in any other clinical study, with the exception of observational long-term follow-up.
  • Subject is allergic to, or has sensitivity to, the study drug or its excipients.
  • Documented symptomatic, progressive or new bone metastases following the first-line chemotherapy with or without radiation therapy (biphosphonate use for prophylaxis or as a maintenance therapy is allowed).
  • No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.

About this study

Official title: A Randomized Phase 2 Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients

The main objective of this study is to investigate whether administration of maintenance temozolomide following standard treatment could possibly prevent or delay the onset of brain metastases in patients with controlled non-small cell lung cancer (NSCLC).

Read the detailed description

This is a Phase 2, open-label, randomized, multicenter study of maintenance temozolomide versus observation in subjects with stable or responding stage III/IV NSCLC to be conducted in conformance with Good Clinical Practices. Subjects will be randomly assigned to a study drug (temozolomide) or observation arm. The study drug will be administered at a dose of 75 mg/m^2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first. Subjects completing 6 cycles of treatment will be followed up for incidence of brain metastasis for up to 2 years, or until progression.

Being tested
Temozolomide
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Carcinoma, Large Cell, Carcinoma, Squamous Cell

What participants receive

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

  • TemozolomideDrug

    Also called Temodar®, SCH 52365

    5-mg, 20-mg, and 100-mg gel capsules, 75 mg/m^2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first.

Study groups in NCT00632203
Study groupRoleWhat they receive
Temozolomide treatmentExperimentalSubjects will receive temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first.
Receives: Drug: Temozolomide
ObservationNo interventionObservation

What is being measured

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

  1. Number of Participants Who Had Brain Metastases

    Brain Metastases were defined as radiological evidence of brain metastases on magnetic resonance imaging (MRI).

    Measured: Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy)

Secondary outcomes (6)

  1. Time to Radiological Central Nervous System (CNS) Progression

    Defined as CNS progression as measured by MRI.

    Time to CNS progression was analyzed using the Kaplan-Meier method.

    Measured: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to radiological progression or the last known CNS progression-free date

  2. Time to Progression

    The time to progression (per response evaluation criteria in solid tumors [RECIST]) was analyzed using the Kaplan-Meier method.

    Definitions of response per RECIST:

    Complete Response (CR): Disappearance of all target lesions.

    Partial Response (PR): A decrease of at least 30% in the sum of the longest

    diameter of target lesions.

    Progressive Disease (PD): An increase of at least 20% in the sum of the longest

    diameter of target lesions.

    Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.

    Measured: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to progression or up to 6 cycles (168 days) of study treatment

  3. Overall Survival

    The overall survival was analyzed using the Kaplan-Meier method.

    Measured: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up

  4. Number of Participants With Brain Metastases at First Progression

    Brain Metastases were defined as radiological evidence of brain metastases on MRI.

    Measured: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)

  5. Cancer-related Quality of Life (QoL) as Assessed by The European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire C30 Version 3.0 (QLQ-C30), and the EORTC Lung Cancer Module (QLQ-LC13)

    The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Scores range from 0 -100. For functional and global QoL scales, higher scores mean a better level of function. For symptom-oriented scales, a higher score means more severe symptoms and a decrease in QoL. The EORTC QLQ-LC13 is a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It has a score range 0-100 with higher scores representing an increase in symptoms.

    Measured: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)

  6. Tolerability of Maintenance Temozolomide

    Tolerability was defined as number of participants with any adverse event leading to study discontinuation and/or study drug discontinuation.

    Measured: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)

Timeline

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

  1. First posted10 Mar 2008 (estimated)
  2. Study start4 Mar 2008
  3. Primary completion6 Jan 2011
  4. Study completion7 Jan 2011

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
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00632203
Sponsor's protocol ID
P05146
Status last verified
May 2017
First submitted
29 Feb 2008
Last updated
7 Jun 2017
Data monitoring committee
No
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

  • Boggs DH, Robins HI, Langer CJ, Traynor AM, Berkowitz MJ, Mehta MP. Strategies to prevent brain metastasis in high-risk non-small-cell lung cancer: lessons learned from a randomized study of maintenance temozolomide versus observation. Clin Lung Cancer. 2014 Nov;15(6):433-40. doi: 10.1016/j.cllc.2014.06.008. Epub 2014 Jun 24.

    PubMed 25069747

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temozolomide in people with Carcinoma, Non-Small-Cell Lung and Adenocarcinoma, run by Merck Sharp & Dohme LLC.

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 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 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Had Brain Metastases (time frame: Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy)). 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 NCT00632203, which also lists 1 linked publication.

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 7 Jun 2017.

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