Status:
COMPLETED
Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Schering-Plough
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00740636
Start Date
August 1 2008
End Date
February 1 2013
Last Update
August 1 2016
Active Locations (5)
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1
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
2
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
4
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570