Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT00096447 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-02631GOG-0229DU10CA027469CDR0000393398
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Endometrial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients With Progression-free Survival > 6 Months

  Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

  For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.

• Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0

  The frequency and severity of all toxicities are tabulated.

  Every cycle during treatment and 30 days after the last cycle of therapy.

Secondary Outcomes (5)

• Percentage of Patients With Tumor Response

  For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.

• Duration of Progression-free Survival

  Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.

• Overall Survival

  From study entry to death or last contact, up to 5 years.

• Prognostic Factors (Performance Status)

  Baseline

• Prognostic Factor (Histologic Grade)

  Baseline

Study Arms (1)

Treatment (lapatinib ditosylate)

EXPERIMENTAL

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

Interventions

lapatinib ditosylate DRUG

Also known as: GSK572016, GW-572016, GW2016, Lapatinib, Tykerb

Treatment (lapatinib ditosylate)

Eligibility Criteria

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

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)

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

Conditions

Endometrial Neoplasms

Interventions

Lapatinib; N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl-6-(5-((methylsulfonyl)ethyl)aminomethyl)-2-furyl)-4-quinazolinamine

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The clinical trial was a two-stage design, accruing approximately 25 patients in each stage. Results from a planned interim futility analysis resulted in the early closure of the study. This study stopped early for lack of treatment efficacy.

Results Point of Contact

• Title: Angela M. Kuras, Associate Director of Data Management
• Organization: NRG Oncology Statistics and Data Management Center - Buffalo

kurasa@nrgoncology.org

716-845-7733

Study Officials

• Kimberly Leslie

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: November 9, 2004
• First Posted: November 10, 2004
• Study Start: November 1, 2004
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 24, 2019
• Results First Posted: September 18, 2015

Record last verified: 2019-07

Locations

US (1)