Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00096447
First received: November 9, 2004
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:
  • Progression-free survival [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    The frequency and severity of all toxicities are tabulated.


Secondary Outcome Measures:
  • Frequency of clinical response (complete and partial response) according to RECIST [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Duration of progression-free survival [ Time Frame: From study entry until disease recurrence, death, or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    Conducted against the historical controls using a proportional hazards model that includes histological grade, performance status, and platinum sensitivity.

  • Duration of overall survival [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Prognostic factors (initial performance status and histological grade) [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: November 2004
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:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096447

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Kimberly Leslie Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096447     History of Changes
Other Study ID Numbers: NCI-2012-02631, GOG-0229D, U10CA027469, CDR0000393398
Study First Received: November 9, 2004
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Lapatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014