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AzTrials

Bladder CancerPhase 1NCT00313599

Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing lapatinib and paclitaxel in people with Bladder Cancer and Brain and Central Nervous System Tumors, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lapatinib and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
Feb 2006to Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
lapatinib, paclitaxel
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
Medical subject headings
Urinary Bladder Neoplasms, Central Nervous System Neoplasms, Breast Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lapatinibDrug

    Also called Tykerb, Tyverb, lapatinib ditosylate

  • paclitaxelDrug

    Also called paclitaxel albumin-stabilized nanoparticle formulation, Abraxane, Taxol

Study groups in NCT00313599
Study groupRoleWhat they receive
Lapatinib and PaclitaxelExperimentalLapatinib 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.
Receives: Drug: lapatinib; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: estimated to be 12 weeks

Secondary outcomes (3)

  1. Toxicity

    Measured: up to 12 weeks

  2. Anti-tumor efficacy and safety every 8 weeks

    Measured: until disease progression estimated to be 12 weeks

  3. Pharmacokinetics during the first 2 weeks of treatment

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00313599
Sponsor's protocol ID
UCSF CC#05591
Status last verified
Jul 2014
First submitted
11 Apr 2006
Last updated
2 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19706807

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lapatinib and paclitaxel in people with Bladder Cancer and Brain and Central Nervous System Tumors, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of lapatinib in course 1 (time frame: estimated to be 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00313599, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.

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