R115777 in Treating Patients With Relapsed Small Cell Lung Cancer

November 8, 2012 updated by: NYU Langone Health

A Phase II Study to Determine the Antitumor Activity of Farnesyltransferase Inhibitor R115777 in Subjects With Relapsed Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have relapsed small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the objective response rate (complete or partial) and duration of response of patients with small cell lung cancer who have had at least a partial response to one prior chemotherapy regimen for at least 3 months when treated with R115777. II. Determine the time to disease progression, survival, and quality of life in this patient population treated with this drug. III. Assess the safety of R115777 in this patient population. IV. Assess the presence of ras mutations in relapsed patients with available paraffin blocks.

OUTLINE: This is a multicenter study. Patients receive oral R115777 every 12 hours for 14 consecutive days followed by 7 days of rest. Treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, on day 15 of each course, and at the end of the study.

PROJECTED ACCRUAL: A total of 27-40 patients will be accrued for this study.

Study Type

Interventional

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 York
      • New York, New York, United States, 10016
        • Kaplan Cancer Center

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

DISEASE CHARACTERISTICS: Histologically confirmed small cell lung cancer for which no potentially curative therapy exists Confirmation at relapse required only if sole relapse site is within previous radiation port No mixed histology Bidimensionally measurable disease by CT scan At least 1 measurable lesion at least 2 cm At least a partial response to front line chemotherapy Single regimen or alternating regimen allowed No initial course exceeding 8 courses or lasting more than 6 months No uncontrolled, untreated brain metastases No extensive liver metastases such that greater than 50% of liver parenchyma is replaced with metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if documented liver metastases) Renal: Creatinine less than 2.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study Adequate unassisted oral or adequate enteral intake to maintain reasonable state of nutrition No other concurrent medical condition that would preclude study therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation No concurrent immunotherapy No concurrent myeloid colony stimulating factors (e.g., filgrastim (G-CSF), sargramostim (GM-CSF), interleukin-11) Chemotherapy: See Disease Characteristics At least 3 months since prior chemotherapy measured from day 1 of last course of front line therapy No prior high dose chemotherapy with marrow or stem cell rescue No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: At least 2 weeks since prior radiotherapy No prior extensive radiotherapy (greater than 25% of bone marrow) No concurrent radiotherapy except for patients who are responding and develop brain metastases Surgery: Not specified Other: At least 30 days since prior investigational drugs No concurrent participation in another investigational trial No other concurrent experimental agents No other concurrent anticancer therapy No prophylactic oral or IV antibiotics for neutropenia

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

Collaborators and Investigators

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

Sponsor

NYU Langone Health

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Abraham Chachoua, MD, NYU Langone Health

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

September 1, 1999

Primary Completion (Actual)

May 1, 2000

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

June 17, 2004

First Posted (Estimate)

June 18, 2004

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067632
  • NYU-9861
  • JRF-R115777-USA-8B
  • NCI-G00-1714

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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