Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT ID: NCT00096447

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2011-03-31

Brief 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

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.

Conditions

Recurrent Endometrial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

lapatinib ditosylate

Intervention Type: DRUG

Interventions

lapatinib ditosylate

Intervention Type: DRUG

Other Intervention Names

GSK572016; GW-572016; GW2016; Lapatinib; Tykerb

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Oncology Group

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly Leslie

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

GOG-0229D

Identifier Type: -

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000393398

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02631

Identifier Type: -

Identifier Source: org_study_id