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

NCT00632203 | Terminated Phase 2 Results

• 1 other identifier: P05146
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Carcinoma, Large Cell; Carcinoma, Squamous Cell

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Brain Metastases

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

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

Secondary Outcomes (6)

• Time to Radiological Central Nervous System (CNS) Progression

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

• Time to Progression

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

• Overall Survival

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

• Number of Participants With Brain Metastases at First Progression

  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)

• 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)

  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)

Study Arms (2)

Temozolomide treatment

EXPERIMENTAL

Subjects 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.

Drug: Temozolomide

Observation

NO INTERVENTION

Observation

Interventions

Temozolomide DRUG

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.

Also known as: Temodar®, SCH 52365

Temozolomide treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 25069747 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Carcinoma, Large Cell; Carcinoma, Squamous Cell

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The interpretation of the study results should be taken with caution because of the small sample size due to early termination.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: March 4, 2008
• Primary Completion: January 6, 2011
• Study Completion: January 7, 2011
• Last Updated: June 7, 2017
• Results First Posted: March 26, 2012

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share