Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors
This study is currently recruiting participants.
Verified January 2013 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00313599
First received: April 11, 2006
Last updated: January 17, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Bladder Cancer
Breast Cancer
Cancer
Esophageal Cancer
Esophagus Disorders
Lung Cancer
Ovarian Cancer
Prostate Cancer
Stomach Cancer
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Maximum tolerated dose (MTD) of lapatinib in course 1 [ Time Frame: estimated to be 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Toxicity [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
- Anti-tumor efficacy and safety every 8 weeks [ Time Frame: until disease progression estimated to be 12 weeks ] [ Designated as safety issue: Yes ]
- Pharmacokinetics during the first 2 weeks of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
Drug: paclitaxel
Other Names:
|
Detailed Description:
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313599
Locations
| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Study Chair: | Mark M. Moasser, MD | University of California, San Francisco |
More Information
Additional Information:
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00313599 History of Changes |
| Other Study ID Numbers: | UCSF CC#05591 |
| Study First Received: | April 11, 2006 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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:
|
Urinary Bladder Neoplasms Breast Neoplasms Esophageal Diseases Esophageal Neoplasms Lung Neoplasms Stomach Neoplasms Nervous System Neoplasms Ovarian Neoplasms Prostatic Neoplasms Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms |
Urinary Bladder Diseases Urologic Diseases Breast Diseases Skin Diseases Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Head and Neck Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Stomach Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013