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Recurrent Endometrial CarcinomaPhase 2NCT00096447

Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase 2 study testing lapatinib ditosylate in people with Recurrent Endometrial Carcinoma, 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

This phase II trial is studying how well lapatinib works in treating patients with recurrent or persistent endometrial cancer. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent Endometrial Carcinoma
What is being tested?
lapatinib ditosylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
Nov 2004to Mar 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed endometrial carcinoma
  • Recurrent or persistent disease
  • Histologic confirmation of the original primary tumor is required
  • Refractory to curative therapy or standard treatments
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan
Show all 49Show fewer
  • Must have at least 1 target lesion
  • Tumors within a previously irradiated field are considered non-target lesions
  • Disease in an irradiated field as the only site of measurable disease is considered a target lesion provided there has been clear progression of the lesion since the completion of prior radiotherapy
  • Must have received 1 prior chemotherapy regimen for endometrial carcinoma
  • Initial therapy may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • No more than 1 additional prior cytotoxic regimen for recurrent or persistent disease
  • Tumor accessible to guided core needle or fine needle biopsy
  • Ineligible for a higher priority GOG protocol (e.g., any active GOG phase III protocol for the same patient population)
  • Performance status - GOG 0-2 (for patients who have received 1 prior treatment regimen)
  • Performance status - GOG 0-1 (for patients who have received 2 prior treatment regimens)
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Cardiac ejection fraction normal by echocardiogram or MUGA
  • No gastrointestinal (GI) tract disease resulting in an inability to take oral medication
  • No malabsorption syndrome
  • No requirement for IV alimentation
  • No uncontrolled inflammatory GI disease (e.g., Crohn's or ulcerative colitis)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No sensory or motor neuropathy > grade 1
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to lapatinib
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • At least 4 weeks since prior immunologic agents for the malignant tumor
  • No prior trastuzumab (Herceptin^®) or any target-specific therapy directed to the HER family (e.g., gefitinib, erlotinib, or cetuximab)
  • At least 6 weeks since prior nitrosoureas or mitomycin for the malignant tumor and recovered
  • No prior non-cytotoxic chemotherapy for recurrent or persistent disease
  • At least 1 week since prior hormonal therapy for the malignant tumor
  • Concurrent hormone replacement therapy allowed
  • Recovered from prior radiotherapy
  • Recovered from prior surgery
  • No prior surgery affecting absorption
  • At least 4 weeks since other prior therapy for the malignant tumor
  • No prior lapatinib
  • No prior anticancer treatment that would preclude study treatment
  • Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased monitoring of INR
  • No concurrent CYP3A4 inducers or inhibitors
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Phase II Evaluation Of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989) In The Treatment Of Persistent Or Recurrent Endometrial Carcinoma

This phase II trial is studying how well lapatinib works in treating patients with recurrent or persistent endometrial cancer. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the 6-month progression-free survival of patients with recurrent or persistent endometrial carcinoma treated with lapatinib.

II. Determine the nature and degree of toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

  1. Determine the objective response rate in patients treated with this drug. II. Determine the duration of progression-free survival and overall survival in patients treated with this drug.

III. Determine the effects of prognostic factors, such as initial performance status and tumor grade, in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-82 patients will be accrued for this study within 30-67 months.

Being tested
lapatinib ditosylate
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • lapatinib ditosylateDrug

    Also called GSK572016, GW-572016, GW2016, Lapatinib

Study groups in NCT00096447
Study groupRoleWhat they receive
Treatment (lapatinib ditosylate)ExperimentalPatients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: lapatinib ditosylate

What is being measured

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

  1. Percentage of Patients With Progression-free Survival > 6 Months

    Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

    Measured: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.

  2. Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0

    The frequency and severity of all toxicities are tabulated.

    Measured: Every cycle during treatment and 30 days after the last cycle of therapy.

Secondary outcomes (5)

  1. Percentage of Patients With Tumor Response

    Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.

  2. Duration of Progression-free Survival

    Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

    Measured: Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.

  3. Overall Survival

    The observed length of life from entry into the study to death or the date of last contact.

    Measured: From study entry to death or last contact, up to 5 years.

  4. Prognostic Factors (Performance Status)

    Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction.

    Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.

    Measured: Baseline

  5. Prognostic Factor (Histologic Grade)

    G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.

    Measured: Baseline

Timeline

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

  1. First posted10 Nov 2004 (estimated)
  2. Study startNov 2004
  3. Primary completionMar 2011
  4. Study completionMar 2011

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096447
Sponsor's protocol ID
NCI-2012-02631
Other IDs
GOG-0229D, U10CA027469, CDR0000393398
Status last verified
Jul 2019
First submitted
9 Nov 2004
Last updated
24 Jul 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lapatinib ditosylate in people with Recurrent Endometrial Carcinoma, 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 49 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 Jul 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients With Progression-free Survival > 6 Months (time frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.). 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 NCT00096447.

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 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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