A Phase II Trial of R115777, a Farnesyl Transferase Inhibitor, in Combination With Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer (NSCLC)
18 Years
N/A
Both
Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Trial Information
A Phase II Trial of R115777, a Farnesyl Transferase Inhibitor, in Combination With Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer (NSCLC)
PRIMARY OBJECTIVES:
I. To describe the response rate in non-small cell lung cancer (NSCLC) patients receiving
combination therapy with R115777, gemcitabine, and cisplatin.
SECONDARY OBJECTIVES:
I. To estimate the time to event efficacy variables including: time to progressive disease,
time to treatment failure, time to death of any cause.
II. To estimate the duration of response for responding patients. III. To characterize the
toxicities of R115777, gemcitabine, and cisplatin in this patient population.
TERTIARY OBJECTIVES:
I. To evaluate the association between polymorphism expression in candidate genes and
clinical endpoints and toxicity to R115777, gemcitabine, and cisplatin.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-14, gemcitabine IV over 30 minutes on
days 1 and 8, and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up
to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with at least stable disease may continue to receive oral tipifarnib alone twice
daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 6 months for 2 years.
Inclusion Criteria:
- Histologically confirmed NSCLC with one of the following classifications:
- Stage IIIB with pleural effusion
- Stage IIIB and not a candidate for combined modality treatment with radiation
therapy and chemotherapy
- Stage IV
- Measurable disease, defined as at least one lesion whose longest diameter can be
accurately measured as >= 2.0 cm
- Absolute neutrophil count (ANC) >= 1500/mm^3
- PLT >= 100,000
- Hgb > 10.0 g/dL
- Direct bilirubin =< 1.5 x UNL
- Alkaline phosphatase =< 5 x UNL
- AST =< 3 x UNL
- Creatinine =< 1.5 x UNL
- ECOG Performance Status (PS) 0 or 1
- Capable of understanding the investigational nature, potential risks and benefits of
the study and able to provide valid informed consent
Exclusion Criteria:
- Any of the following as this regimen may be harmful to a developing fetus or nursing
child:
- Pregnant women
- Breastfeeding women
- Men or women of childbearing potential or their sexual partners who are
unwilling to employ adequate contraception (condoms, diaphragm, birth control
pills, injections, intrauterine device [IUD], surgical sterilization,
subcutaneous implants, or abstinence, etc.)
- Any of the following prior therapies:
- Prior chemotherapy for NSCLC (exception: therapies used as a radiosensitizer
such as low-dose weekly cisplatin and carbo/taxol with XRT)
- Prior radiation > 25% of bone marrow
- Prior immunotherapy, biologic or gene therapy
- New York Heart Association classification III or IV
- CNS metastases
- Uncontrolled infection
- Any other severe, underlying diseases that are, in the judgment of the investigator,
inappropriate for entry into this study
- Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, adequately treated noninvasive carcinomas, or other cancer from which the
patient has been disease-free for at least five years
- Pre-existing peripheral neuropathy (motor or sensory) > grade 1 per NCI Common
Toxicity Criteria (CTC)
- Known peripheral vascular disease or a history of deep vein thrombosis
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
Outcome Description:
Ninety-five percent confidence intervals for the true success proportion will be calculated.
Outcome Time Frame:
Up to 18 weeks (6 courses)
Safety Issue:
No
Principal Investigator
Alex Adjei
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02808
NCT ID:
NCT00055757
Start Date:
October 2003
Completion Date:
Related Keywords:
- Stage IIIB Non-Small Cell Lung Cancer
- Stage IV Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
