Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer

NCT00027690 | Completed Phase 2

• 4 other identifiers: NCI-2012-02429CDR0000069057GOG-0229CU10CA027469
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of gefitinib in treating patients who have persistent or recurrent endometrial cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of endometrial cancer.

Conditions

Recurrent Uterine Corpus Carcinoma

Outcome Measures

Primary Outcomes (2)

• Proportion of patients alive and progression-free

  6 months

• Frequency and severity of adverse effects as assessed by National Cancer Institute Common Toxicity Criteria (CTC) v2.0

  Up to 5 years

Secondary Outcomes (5)

• Duration of progression-free survival

  Up to 5 years

• Duration of overall survival

  Up to 5 years

• Frequency of clinical response utilizing the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria

  Up to 5 years

• Numerical descriptions of serum concentrations of gefitinib, gefitinib activity, and soluble epidermal growth factor receptor (EGFR)

  Baseline to end of course 5

• Initial performance status and histological grade

  Baseline to end of course 5

Study Arms (1)

Treatment (gefitinib)

EXPERIMENTAL

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Gefitinib; Other: Laboratory Biomarker Analysis

Interventions

Gefitinib DRUG

Given orally

Also known as: ZD 1839

Treatment (gefitinib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (gefitinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed primary endometrial carcinoma
• Recurrent or persistent disease
• Received 1 prior chemotherapy regimen for endometrial carcinoma
• Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or nonsurgical assessment
• At least 1 unidimensionally measurable lesion
• At least 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, and MRI)
• At least 10 mm by spiral CT scan
• Must have at least 1 target lesion for response assessment
• Tumors within a previously irradiated field are designated as non-target lesions
• Disease in a previously irradiated field as the only site of measurable disease is allowed only if there has been clear progression of the lesion since the completion of radiotherapy
• Must have a tumor that is accessible for guided core needle or fine needle biopsy
• Ineligible for a higher priority GOG protocol, defined as any active phase III protocol for the same patient population, if one exists
• Performance status - GOG 0-2 (for patients who received 1 prior regimen)
• Performance status - GOG 0-1 (for patients who received 2 prior regimens)
• Absolute neutrophil count at least 1,500/mm\^3

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Interventions

Gefitinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kimberly Leslie

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2002
• Primary Completion: September 1, 2004
• Study Completion: July 1, 2013
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (1)