Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small… (NCT00254384) | Clinical Trial Compass
CompletedPhase 1
Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small Cell Lung Cancer Following Surgery
United States50 participantsStarted 2005-10-05
Plain-language summary
This phase I trial studies docetaxel, cisplatin, and erlotinib hydrochloride in treating patients with stage I-III non-small cell lung cancer following surgery. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel, cisplatin, and erlotinib hydrochloride together may kill more tumor cells.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed diagnosis of stage I, II or III non-small cell lung cancer; tissue blocks or slides will be requested
* Patients must have surgically resectable disease and may not be treated with prior chemotherapy or radiation
* Patients must be able to tolerate systemic chemotherapy prior to surgical resection
* No acute intercurrent illness or infection
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Leukocytes \>= 3,000/uL
* Absolute neutrophil count (ANC) \>= 1,500/uL
* Platelets \>= 100,000/uL
* Hemoglobin \>= 8g/dL
* Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Bilirubin within normal institutional limits
* Alkaline phosphatase (alk phos) =\< 2.5 x upper limit of normal (ULN); if alk phos \> 2.5 x ULN but =\< 5 x ULN, patient is eligible if AST or ALT =\< ULN
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 1.5 x ULN; if AST or ALT \> 1.5 x ULN but =\< 5 x ULN, patient is eligible if alk phos is =\< ULN
* Prior to study enrollment, all women of child-bearing potential must have a negative pregnancy test; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months after the completion of t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of grade 3 or greater toxicities (hematologic or non-hematologic)
Timeframe: Up to 5 years post-treatment
2
Changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue
Timeframe: From baseline up to 5 years post-treatment