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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00042809

Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing paclitaxel, trastuzumab and erlotinib hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) 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

Phase I trial to study the effectiveness of combining erlotinib and trastuzumab with paclitaxel in treating patients who have advanced solid tumors. Biological therapies such as erlotinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
paclitaxel, trastuzumab and erlotinib hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
May 2002to Dec 2007
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

Who may be able to join

  • Histologically confirmed metastatic solid tumor for which there are no effective standard treatment options
  • HER2 positive (1+ to 3+)
  • Tumor has a high likelihood of expressing epidermal growth factor receptor (EGFR)
  • No evidence of leptomeningeal disease or brain metastases unless previously treated, currently asymptomatic, and off both antiepileptics and dexamethasone
  • Patients with treated brain metastases are eligible if they are without any clinical change in their brain disease status for at least 4 weeks after whole brain irradiation
  • Performance status - ECOG 0-2
Show all 45Show fewer
  • Performance status - Karnofsky 60-100%
  • At least 12 weeks
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver has tumor involvement)
  • Creatinine normal
  • Creatinine clearance at least 60 mL/min
  • LVEF more than 50% by radionuclide ventriculogram or MUGA scan
  • No significant cardiovascular disease
  • No prior congestive heart failure requiring therapy
  • No unstable angina pectoris
  • No myocardial infarction within the past 6 months
  • No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
  • Patients who are unable to swallow tablets and/or who have silicon-based G-tubes may dissolve the tablets in distilled water
  • No active peptic ulcer disease
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known or suspected hypersensitivity to paclitaxel
  • No prior allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or other study agents
  • No concurrent active infection
  • No other concurrent medical condition that would preclude study participation
  • No persistent grade 2 or greater neurotoxicity/neuropathy from any cause
  • No psychiatric disorders or altered mental status that would preclude study participation
  • No other concurrent immunotherapy
  • No concurrent cytokine growth factors (e.g., colony-stimulating factors)
  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No other concurrent chemotherapy
  • See Disease Characteristics
  • No concurrent hormonal therapy except megestrol as an appetite stimulant or luteinizing hormone-releasing hormone agonists for prostate cancer
  • See Disease Characteristics
  • No concurrent radiotherapy
  • No prior surgical procedures affecting absorption
  • No prior EGFR-targeting therapy
  • No other concurrent experimental medications or other specific antitumor therapy
  • No concurrent immunosuppressant therapy
  • No concurrent antiarrhythmic therapy for a ventricular arrhythmia

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Phase I Study To Determine The Safety, Tolerance And Preliminary Antineoplastic Activity Of Combined EGFR (erbB1) And HER2 (erbB2) Blockade, With OSI-774 And Trastuzumab, In Combination With Weekly Paclitaxel

Phase I trial to study the effectiveness of combining erlotinib and trastuzumab with paclitaxel in treating patients who have advanced solid tumors. Biological therapies such as erlotinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and trastuzumab with paclitaxel may kill more tumor cells

Read the detailed description

OBJECTIVES:

  1. Determine the safety, quantitative and qualitative toxic effects, maximum tolerated dose, and dose-limiting toxic effects of erlotinib when combined with paclitaxel and trastuzumab (Herceptin) in patients with advanced solid tumors.

II. Determine the relevant pharmacokinetic interactions between these agents in these patients.

III. Determine, preliminarily, the antitumor activity of this regimen in these patients.

OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of erlotinib.

Intermittent schedule: Patients receive paclitaxel IV over 1 hour followed 30 minutes later by trastuzumab (Herceptin) IV over 30 minutes on days 1, 8, and 15 of each course. Patients also receive oral erlotinib once daily on days 3-28 of course 1 and on days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Continuous schedule: Once the MTD is determined using the intermittent schedule, an additional 12 patients are accrued to study the tolerability of a continuous schedule comprising paclitaxel and trastuzumab as above on days 1, 8, 15, and 22 and oral erlotinib once daily on days 3-28 during course 1 and on days 1-28 of subsequent courses using the same dose-escalation scheme as above. Courses repeat as above.

Patients are followed every 30 days.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 10-13.3 months.

Being tested
paclitaxel, trastuzumab, erlotinib hydrochloride, laboratory biomarker analysis, pharmacological study

What participants receive

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

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • trastuzumabBiological

    Also called anti-c-erB-2, Herceptin, MOAB HER2

    Given IV

  • erlotinib hydrochlorideDrug

    Also called CP-358,774, erlotinib, OSI-774

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00042809
Study groupRoleWhat they receive
Treatment (paclitaxel, trastuzumab, erlotinib hydrochloride)ExperimentalSee detailed description.
Receives: Drug: paclitaxel; Biological: trastuzumab; Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

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

  1. Maximally tolerated dose (MTD), graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

    Measured: Up to day 28

  2. Response rates, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: Up to 6 years

Secondary outcomes (1)

  1. Incidence of adverse events, graded according to the NCI CTC v2.0

    Measured: Up to 30 days after last study treatment

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2002
  3. Primary completionDec 2007

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00042809
Sponsor's protocol ID
NCI-2012-02477
Other IDs
IDD #01-35, U01CA069853, CDR0000069472
Status last verified
Jan 2013
First submitted
5 Aug 2002
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing paclitaxel, trastuzumab and erlotinib hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) 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?

The sponsor lists 45 inclusion and 0 exclusion criteria. 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 24 Jan 2013. 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?

Maximally tolerated dose (MTD), graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 (time frame: Up to day 28). The study lists 2 primary outcomes in all. 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 NCT00042809.

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 24 Jan 2013.

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