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Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tipifarnib
cisplatin
gemcitabine hydrochloride
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IIIB Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (tipifarnib, gemcitabine, cisplatin)

Arm Description

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.

Outcomes

Primary Outcome Measures

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
Ninety-five percent confidence intervals for the true success proportion will be calculated.

Secondary Outcome Measures

Survival time
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time to disease progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented
Time to treatment failure

Full Information

First Posted
March 6, 2003
Last Updated
June 3, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00055757
Brief Title
Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title
A Phase II Trial of R115777, a Farnesyl Transferase Inhibitor, in Combination With Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of combining tipifarnib with gemcitabine and cisplatin in treating patients who have stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy such as gemcitabine and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining tipifarnib with combination chemotherapy may kill more tumor cells.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (tipifarnib, gemcitabine, cisplatin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
tipifarnib
Other Intervention Name(s)
R115777, Zarnestra
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CACP, CDDP, CPDD, DDP
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
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
Description
Ninety-five percent confidence intervals for the true success proportion will be calculated.
Time Frame
Up to 18 weeks (6 courses)
Secondary Outcome Measure Information:
Title
Survival time
Description
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time Frame
Time from registration to death due to any cause, assessed up to 2 years
Title
Time to disease progression
Description
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time Frame
Time from registration to documentation of disease progression, assessed up to 2 years
Title
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented
Time Frame
Up to 2 years
Title
Time to treatment failure
Time Frame
Time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Adjei
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

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