CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
Temozolomide +1 moredrug
Likely dose
Temozolomide 75 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00740636
NCT00740636Phase 2Completed

Phase II Study of Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

Memorial Sloan Kettering Cancer Center·interventional·Posted Aug 25, 2008·Updated Aug 1, 2016

In Brief

A Phase 2 clinical trial evaluating Temozolomide for Lung Cancer. Completed, enrolled 92 participants across 5 sites.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsSchering-Plough

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 25, 2008
Enrollment StartAug 1, 2008
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.9 years ago

Interventions

Temozolomidedrug

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.

Temozolomidedrug

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.