Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors

NCT00313599 | Completed Phase 1 DMC

• 1 other identifier: UCSF CC#05591
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Brain and Central Nervous System Tumors; Breast Cancer; Esophageal Cancer; Extragonadal Germ Cell Tumor; Gastric Cancer; Lung Cancer; Ovarian Cancer; Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of lapatinib in course 1

  estimated to be 12 weeks

Secondary Outcomes (3)

• Toxicity

  up to 12 weeks

• Anti-tumor efficacy and safety every 8 weeks

  until disease progression estimated to be 12 weeks

• Pharmacokinetics during the first 2 weeks of treatment

  2 weeks

Study Arms (1)

Lapatinib and Paclitaxel

EXPERIMENTAL

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; Drug: paclitaxel

Interventions

lapatinib DRUG

Also known as: Tykerb, Tyverb, lapatinib ditosylate

Lapatinib and Paclitaxel

paclitaxel DRUG

Also known as: paclitaxel albumin-stabilized nanoparticle formulation, Abraxane, Taxol

Lapatinib and Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• Chien 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 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Central Nervous System Neoplasms; Breast Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Dysgerminoma; Carcinoma, Ovarian Epithelial

Interventions

Lapatinib; Paclitaxel; Taxes; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Nervous System Neoplasms; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Mark M. Moasser, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 12, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 2, 2014

Record last verified: 2014-07

Locations

US (1)