Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors (NCT00313599) | Clinical Trial Compass
CompletedPhase 1
Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors
United States28 participantsStarted 2006-02
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may help paclitaxel work better by making tumor cells more sensitive to the drug. Lapatinib may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving lapatinib together with paclitaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with paclitaxel in treating patients with advanced solid tumors.
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.
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor, including the following tumor types:
* Breast cancer
* Non-small cell lung cancer
* Prostate cancer
* Bladder cancer
* Gastroesophageal junction cancer
* Ovarian cancer
* Germ cell tumor
* Advanced or metastatic disease
* No effective curative therapy exists
* Evaluable disease
* Measurable disease not required
* Bone-only disease allowed
* No progressing brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* Absolute neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* Bilirubin normal
* AST/ALT ≤ 2.5 times upper limit of normal
* Creatinine normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious intercurrent medical or psychiatric illness
* No serious active infection
* No gastrointestinal tract disease that would impair a patient's ability to take oral medication
* No history of significant cardiac disease, including any of the following:
* Congestive heart failure
* Symptomatic cardiac arrhythmias
* Unstable angina
* No pre-existing peripheral neuropathy ≥ 2
PRIOR CONCURRENT THERAPY:
* Any number of prior therapies allowed
* Prior paclitaxel, tyrosine kinase inhibitor therapy, or endothelial growth factor inhibitors allowed
* At least 14 days since prior and no concurrent CYP3A4 inducers or herbal or dietary supplements
* At …
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
Maximum tolerated dose (MTD) of lapatinib in course 1