Clinical trial NCT00470067: Doxorubicin Hydrochloride Liposome and Carboplatin in Treating Patients With Recurrent, Stage III, or Stage IV Primary Endometrial Cancer
Official title: A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: recurrent endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2007-05-07
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome together with carboplatin works in treating patients with recurrent, stage III, or stage IV primary endometrial cancer.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Response (Complete and Partial)
timeFrame: Every 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Shashikant B. Lele, MD
role: PRINCIPAL_INVESTIGATOR
References: