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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT00055757 |
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Date of registration:
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06/03/2003 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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A Phase II Trial of R115777, a Farnesyl Transferase Inhibitor, in Combination With Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer (NSCLC) |
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Date of first enrolment:
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October 2003 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00055757 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Alex Adjei |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stage IIIB Non-small Cell Lung Cancer
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Stage IV Non-small Cell Lung Cancer
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Intervention(s)
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Drug: cisplatin
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Drug: gemcitabine hydrochloride
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Drug: tipifarnib
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Other: laboratory biomarker analysis
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Primary Outcome(s)
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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
[Time Frame: Up to 18 weeks (6 courses)]
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Secondary Outcome(s)
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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]
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Survival time
[Time Frame: Time from registration to death due to any cause, assessed up to 2 years]
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Time to disease progression
[Time Frame: Time from registration to documentation of disease progression, assessed up to 2 years]
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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]
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Secondary ID(s)
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CDR0000271196
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MC0123
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N01CM17102
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N01CM17104
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NCI-2012-02808
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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