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Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: November 9, 2004
Last updated: August 18, 2015
Last verified: January 2013
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

Condition Intervention Phase
Recurrent Endometrial Carcinoma
Drug: lapatinib ditosylate
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation Of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989) In The Treatment Of Persistent Or Recurrent Endometrial Carcinoma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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. ]
    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.

  • Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 [ Time Frame: Up to 5 years ]
    The frequency and severity of all toxicities are tabulated.

Secondary Outcome Measures:
  • Percentage of Patients With Tumor Response [ Time Frame: 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. ]
    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.

  • Duration of Progression-free Survival [ Time Frame: From study entry until disease recurrence, death, or date of last contact, assessed up to 5 years ]
    Conducted against the historical controls using a proportional hazards model that includes histological grade, performance status, and platinum sensitivity.

  • Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years. ]
    The observed length of life from entry into the study to death or the date of last contact.

  • Prognostic Factors (Initial Performance Status and Histological Grade) [ Time Frame: Up to 6 years ]

Enrollment: 31
Study Start Date: November 2004
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (lapatinib ditosylate)
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: lapatinib ditosylate
Other Names:
  • GSK572016
  • GW-572016
  • GW2016
  • Lapatinib
  • Tykerb

Detailed Description:


I. 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.


I. 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
    • 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
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Please refer to this study by its identifier: NCT00096447

United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Kimberly Leslie Gynecologic Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00096447     History of Changes
Other Study ID Numbers: NCI-2012-02631
U10CA027469 ( US NIH Grant/Contract Award Number )
CDR0000393398 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: November 9, 2004
Results First Received: June 3, 2015
Last Updated: August 18, 2015

Additional relevant MeSH terms:
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017