Know Cancer

or
forgot password

A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma


OBJECTIVES:

Primary

- Estimate the response rate in patients with recurrent or stage III or IV primary
endometrial carcinoma treated with doxorubicin hydrochloride liposome and carboplatin.

Secondary

- Determine progression-free survival of patients treated with this regimen.

- Determine overall survival of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin
IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 8 courses in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 6 months and then every 3
months thereafter.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary endometrial carcinoma meeting 1 of the following
criteria:

- Stage III or IV disease according to FIGO staging criteria

- Recurrent disease that is considered incurable

- Measurable disease

- A lesion within a previously irradiated field is acceptable as measurable
disease only if there has been clear progression since completion of
radiotherapy

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Creatinine < 2.5 mg/dL OR creatinine clearance ≥ 60 mL/min

- ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN in the presence of
liver metastases)

- Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN in the presence of liver
metastases)

- Total bilirubin ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases)

- Not pregnant or nursing

- Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA scan or ECHO

- No history of severe hypersensitivity reaction to doxorubicin hydrochloride liposome

- No other invasive malignancy (i.e., breast cancer) within the past 5 years except
nonmelanoma skin cancer

- No cardiac disease, including any of the following:

- Myocardial infarction within the past 6 months

- NYHA class II-IV heart failure

- Uncontrolled angina

- Severe uncontrolled ventricular arrhythmias

- Clinically significant pericardial disease

- Acute ischemic or active conduction system abnormalities by ECHO

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy

- No prior cancer therapy that would contraindicate study treatment

- No concurrent investigational agents

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response (complete and partial)

Outcome Time Frame:

Every 28 days

Safety Issue:

No

Principal Investigator

Shashikant B. Lele, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000543389

NCT ID:

NCT00470067

Start Date:

February 2007

Completion Date:

December 2009

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263