Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

July 1, 2016 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memoral Sloan Kettering Cancer Center
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center at Commack
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
      • Sleepy Hollow, New York, United States
        • Memoral Sloan Kettering Cancer Center@Phelps

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 75 mg/m2/day Temozolomide
75 mg/m2/day Temozolomide for 21 days (7 days off treatment). 28 day cycles.
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: 200 mg/m2/day Temozolomide
200 mg/m2/day Temozolomide for 5 days (23 days off treatment). 28 day cycles.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Schering-Plough

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (ESTIMATE)

August 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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