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Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00313599
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : July 2, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Brain and Central Nervous System Tumors Breast Cancer Esophageal Cancer Extragonadal Germ Cell Tumor Gastric Cancer Lung Cancer Ovarian Cancer Prostate Cancer Drug: lapatinib Drug: paclitaxel Phase 1

Detailed Description:



  • Determine the maximum tolerated dose (MTD) of a 2-day pulse of lapatinib that can be given prior to paclitaxel (albumin-stabilized nanoparticle formulation ) (ABI-007; Abraxane™) in patients with advanced solid tumor malignancies.


  • Define the toxicity of this regimen.
  • Determine, preliminarily, the antitumor efficacy and safety of ABI-007 when preceded by a 2-day pulse of lapatinib.
  • Characterize the potential of the molecular markers within circulating tumor cells as markers of response (e.g., HER2 and AKT) or apoptotic markers.
  • Determine whether lapatinib given at MTD prior to ABI-007 alters the pharmacokinetic properties of the paclitaxel component of ABI-007.

OUTLINE: This is a does-escalation study of lapatinib. Patients are stratified according to dose level.

Patients receive oral lapatinib on days 1, 2, 8, 9, 15, and 16 and paclitaxel (albumin-stabilized nanoparticle formulation) (ABI-007; Abraxane™) IV over 30 minutes on days 3, 10, and 17. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of lapatinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicities.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2006
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Lapatinib and Paclitaxel
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.
Drug: lapatinib
Other Names:
  • Tykerb
  • Tyverb
  • lapatinib ditosylate

Drug: paclitaxel
Other Names:
  • paclitaxel albumin-stabilized nanoparticle formulation
  • Abraxane
  • Taxol

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of lapatinib in course 1 [ Time Frame: estimated to be 12 weeks ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: up to 12 weeks ]
  2. Anti-tumor efficacy and safety every 8 weeks [ Time Frame: until disease progression estimated to be 12 weeks ]
  3. Pharmacokinetics during the first 2 weeks of treatment [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313599

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United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
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Study Chair: Mark M. Moasser, MD University of California, San Francisco
Publications of Results:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00313599    
Other Study ID Numbers: UCSF CC#05591
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: July 2014
Keywords provided by University of California, San Francisco:
recurrent breast cancer
stage IV breast cancer
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent prostate cancer
stage IV prostate cancer
recurrent bladder cancer
stage IV bladder cancer
recurrent gastric cancer
stage IV gastric cancer
recurrent esophageal cancer
stage IV esophageal cancer
recurrent ovarian germ cell tumor
stage IV ovarian germ cell tumor
adult central nervous system germ cell tumor
ovarian choriocarcinoma
ovarian dysgerminoma
ovarian embryonal carcinoma
ovarian yolk sac tumor
ovarian mixed germ cell tumor
recurrent ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent extragonadal non-seminomatous germ cell tumor
recurrent extragonadal seminoma
stage IV extragonadal non-seminomatous germ cell tumor
stage IV extragonadal seminoma
recurrent extragonadal germ cell tumor
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Stomach Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Head and Neck Neoplasms
Esophageal Diseases