Clinical trial · Interventional
Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors
A Phase I Dose Escalation Study of a 2 Day Oral Lapatinib Chemosensitization Pulse Given Prior To Weekly Intravenous Abraxane™ in Patients With Advanced Solid Tumors
NCT00313599CI-TRIAL-00014994completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lapatinib | Drug | Lapatinib | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lapatinib and Paclitaxel
- description
- Lapatinib will be self-administered orally on days 1 and 2 of weeks 1, 2, and 3 of a 4-week cycle. Lapatinib is the experimental therapy and is being administered using a dose escalation design guided by careful monitoring of toxicities. Abraxane will be administered IV weekly on day 3 of weeks 1, 2, and 3 of a 4-week cycle. Abraxane is being administered at the well tolerated and effective standard dose and schedule of 100mg/m2 weekly 3 out of 4 weeks as defined by previous phase I and II studies. Patients will continue on therapy as long as they are not experiencing toxicities and there is no evidence of disease progression.
- interventionNames
- Drug: lapatinib
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) of lapatinib in course 1
- timeFrame
- estimated to be 12 weeks
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 least 7 days since prior and no concurrent CYP3A4 inhibitors * At least 6 months since prior and no concurrent amiodarone * More than 1 month since prior chemotherapy, radiotherapy, hormonal therapy, or investigational anticancer agents * Concurrent continued use of gonadal suppression agents (i.e., goserelin acetate or leuprolide acetate) allowed * No antacids 1 hour before and after study drug administration * No concurrent retinoids * No concurrent hormonal anticancer agent * No other concurrent anticancer chemotherapy or investigational anticancer agents
References
Publications (1)
- RESULTChien AJ, Illi JA, Ko AH, Korn WM, Fong L, Chen LM, Kashani-Sabet M, Ryan CJ, Rosenberg JE, Dubey S, Small EJ, Jahan TM, Hylton NM, Yeh BM, Huang Y, Koch KM, Moasser MM. A phase I study of a 2-day lapatinib chemosensitization pulse preceding nanoparticle albumin-bound Paclitaxel for advanced solid malignancies. Clin Cancer Res. 2009 Sep 1;15(17):5569-75. doi: 10.1158/1078-0432.CCR-09-0522. Epub 2009 Aug 25. PMID 19706807