Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

Completed · Phase 2

Conditions studied: Recurrent Endometrial Carcinoma

In brief

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

Key facts

Study ID

NCT00096447

Run by

National Cancer Institute (NCI)

People needed

31

Starts

2004-11-01

Expected to finish

2011-03-01

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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