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Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00740636
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : February 1, 2016
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

August 22, 2008
August 25, 2008
October 20, 2015
February 1, 2016
August 1, 2016
August 2008
February 2013   (Final data collection date for primary outcome measure)
The Objective Overall Response [ Time Frame: 2 years ]

The objective response is defined as all complete responses and partial responses based on the modified RECIST.Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

The objective overall response rate, which will be stratified for sensitive and refractory disease. [ Time Frame: conclusion of study ]
Complete list of historical versions of study NCT00740636 on ClinicalTrials.gov Archive Site
Not Provided
  • Determine the objective response rate to temozolomide in the following patient groups: - Brain Metastases vs. No Brain Metastases and - Second or third line treatment. [ Time Frame: conclusion of study ]
  • Determine the overall survival of patients. [ Time Frame: conclusion of study ]
  • Evaluate available tumor samples for methylated MGMT promotor by PCR and determine if this correlates with response and survival. [ Time Frame: conclusion of study ]
  • Evaluate AGT/MGMT activity in peripheral blood mononuclear cells and determine if this correlates to response and survival, as well as with the presence or absence of the MGMT promoter methylation status in available tissue samples. [ Time Frame: conclusion of the study ]
Not Provided
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Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer
Phase II Study of Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

The purpose of this study is to determine whether treatment with temozolomide will shrink small cell lung cancer tumors. Temozolomide is an oral chemotherapy drug that is currently used to treat brain cancer and melanoma.

As part of this study, we will be doing additional tests that may help us understand how temozolomide works. First, if there is a tumor sample from a biopsy done in the past, it will be analyzed for an abnormal gene that may be present in lung cancer. Before starting temozolomide, a research blood test will be done to look for the same abnormal gene we are looking for in your tumor sample. Also, before starting temozolomide and every time you have a repeat CT scan, a research blood test will be done to analyze the number of tumor cells in your bloodstream.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
  • Drug: Temozolomide
    Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 75 mg/m2/day.
  • Drug: Temozolomide
    Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 200mg/m2/day.
  • Experimental: 75 mg/m2/day Temozolomide
    75 mg/m2/day Temozolomide for 21 days (7 days off treatment). 28 day cycles.
    Intervention: Drug: Temozolomide
  • Experimental: 200 mg/m2/day Temozolomide
    200 mg/m2/day Temozolomide for 5 days (23 days off treatment). 28 day cycles.
    Intervention: Drug: Temozolomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
February 2013
February 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have pathologically confirmed SCLC at MSKCC that has progressed after one or two chemotherapy regimens.
  • At least 3 weeks must have elapsed since last chemotherapy or radiation treatment and initiation of study treatment.
  • Karnofsky performance status > or = to 60%.
  • Patients must have measurable disease, this can include brain metastases.
  • Patients must have normal organ and marrow function as defined below:
  • − leukocytes > 3,000/mcL

    • platelets > 100,000/mcL
    • total bilirubin < 1.5 mg/dL
    • AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal
    • Creatinine < 2.0 mg/dl
  • For women of child-bearing potential, negative pregnancy test within 7 days prior to starting temozolomide.
  • Men and women of childbearing potential must agree to practice adequate contraception.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Both men and women of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

  • Patients who have not recovered from adverse events of previous therapies.
  • Patients receiving other investigational agents.
  • Patients with leptomeningeal involvement.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or HIV-positive patients on combination antiretroviral therapy. However, HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. Excluding patients on HAART is necessary due to the potential for pharmacokinetic interactions with temozolomide.
  • Women who are pregnant or breast feeding, due to possible adverse effects on the developing fetus or infant due to study drug.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00740636
08-065
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Schering-Plough
Principal Investigator: Maria Pietanza, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP