Full Text View
Tabular View
No Study Results Posted
Related Studies
Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients (Study P05146AM4)
This study is currently recruiting participants.
Verified by Schering-Plough, August 2009
First Received: February 29, 2008   Last Updated: August 14, 2009   History of Changes
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00632203
  Purpose

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).


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Carcinoma, Large Cell
Carcinoma, Squamous Cell
Drug: Temozolomide
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy 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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Incidence of brain metastases, according to MRI of the brain, at 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy) [ Time Frame: At 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to radiological or clinical CNS progression; Time to progression; incidence of brain metastases at first progression [ Time Frame: At progression or last known progression-free date ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: At initial follow-up, 30 days after final dose of study drug; then every 12 weeks (+/-1 week) and at 12 months (+/-1 week) from Day 1 Cycle 1 ] [ Designated as safety issue: No ]
  • Cancer-related QoL assessment [ Time Frame: Before the first treatment, at the end of each treatment cycle, and at the end of treatment ] [ Designated as safety issue: No ]
  • Tolerability of maintenance temozolomide [ Time Frame: Before the first treatment, at the end of each treatment cycle, at the end of treatment, and 30 days after the end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Temozolomide treatment: Experimental
Subjects will receive temozolomide at a dose of 75 mg/m2 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
5-mg, 20-mg, and 100-mg gel capsules, 75 mg/m2 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.
Observation: No Intervention
Observation

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/m2 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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.

Exclusion Criteria:

  • Brain metastases documented on post-chemotherapy 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632203

Contacts
Contact: SP Clinical Trial Registry Call Center 1-888-772-8734

  Show 26 Study Locations
Sponsors and Collaborators
Schering-Plough
  More Information

No publications provided

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P05146
Study First Received: February 29, 2008
Last Updated: August 14, 2009
ClinicalTrials.gov Identifier: NCT00632203     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Thoracic Neoplasms
Temozolomide
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Large Cell
Non-small Cell Lung Cancer
Antineoplastic Agents, Alkylating
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Adenocarcinoma
Alkylating Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Temozolomide
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Large Cell
Antineoplastic Agents, Alkylating
Neoplasms, Squamous Cell
Adenocarcinoma
Carcinoma, Squamous Cell
Alkylating Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009