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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Abraham Chachoua, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

September 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Kaplan Cancer Center New York, New York  10016