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Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096447
  Purpose

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with recurrent or persistent endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Drug: lapatinib ditosylate
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Lapatinib Lapatinib Ditosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation Of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989) In The Treatment Of Persistent Or Recurrent Endometrial Carcinoma

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

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]
  • Frequency and severity of adverse events as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of clinical response (complete and partial response) [ Designated as safety issue: No ]
  • Duration of progression-free survival [ Designated as safety issue: No ]
  • Duration of overall survival [ Designated as safety issue: No ]
  • Prognostic factors (initial performance status and histological grade) [ Designated as safety issue: No ]

Study Start Date: November 2004
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 6-month progression-free survival of patients with recurrent or persistent endometrial carcinoma treated with lapatinib.
  • Determine the nature and degree of toxicity of this drug in these patients.

Secondary

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2 (for patients who have received 1 prior treatment regimen)
  • GOG 0-1 (for patients who have received 2 prior treatment regimens)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • Cardiac ejection fraction normal by echocardiogram or MUGA

Gastrointestinal

  • 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)

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • 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)

Chemotherapy

  • See Disease Characteristics
  • 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

Endocrine therapy

  • At least 1 week since prior hormonal therapy for the malignant tumor
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery
  • No prior surgery affecting absorption

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096447

  Show 50 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Kimberly K. Leslie, MD University of New Mexico
Investigator: Russell J. Schilder, MD Fox Chase Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000393398, GOG-0229D
Study First Received: November 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00096447  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma

Study placed in the following topic categories:
Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Lapatinib
Urogenital Neoplasms
Endometrial cancer
Recurrence
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009