Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00740636
First received: August 22, 2008
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • The objective overall response rate, which will be stratified for sensitive and refractory disease. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Determine the overall survival of patients. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • Evaluate available tumor samples for methylated MGMT promotor by PCR as well as MGMT expression by immunohistochemistry and determine if these correlate with response and survival. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To identify and enumerate circulating tumor cells using the Cell SearchTM System in this cohort of patients with SCLC; and determine if the number of circulating tumor cells after each cycle of treatment correlates with response. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine if the CTC-Chip is a viable system to identify and enumerate CTCs in this cohort of patients with SCLC. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The CTC Chip is available at MSKCC and peripheral blood will be collected from patients for quantification of CTCs using this platform. In purple top EDTA tubes, approximately 20ml of peripheral blood will be collected.


Enrollment: 92
Study Start Date: August 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1, Pts with sensitive disease
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.
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: 2, Pts with refractory disease
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.
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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740636

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570
Memoral Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York, United States
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Schering-Plough
Investigators
Principal Investigator: Maria Pietanza, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00740636     History of Changes
Other Study ID Numbers: 08-065
Study First Received: August 22, 2008
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
TEMOZOLOMIDE
Lung

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014