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

NCT00055757 | Completed Phase 2

• 4 other identifiers: NCI-2012-02808MC0123N01CM17104N01CM17102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 18 weeks (6 courses)

Secondary Outcomes (4)

• Survival time

  Time from registration to death due to any cause, assessed up to 2 years

• Time to disease progression

  Time from registration to documentation of disease progression, assessed up to 2 years

• 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

  Up to 2 years

• Time to treatment failure

  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

Study Arms (1)

Treatment (tipifarnib, gemcitabine, cisplatin)

EXPERIMENTAL

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.

Drug: tipifarnib; Drug: cisplatin; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis

Interventions

tipifarnib DRUG

Given orally

Also known as: R115777, Zarnestra

Treatment (tipifarnib, gemcitabine, cisplatin)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (tipifarnib, gemcitabine, cisplatin)

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Treatment (tipifarnib, gemcitabine, cisplatin)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (tipifarnib, gemcitabine, cisplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tipifarnib; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Alex Adjei

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: October 1, 2003
• Primary Completion: April 1, 2004
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)