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Doxorubicin Hydrochloride Liposome and Carboplatin in Treating Patients With Recurrent, Stage III, or Stage IV Primary Endometrial Cancer

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00470067
Enrollment
9
Registered
2007-05-07
Start date
2007-02-28
Completion date
2009-12-31
Last updated
2014-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma

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.

Interventions

DRUGcarboplatin

IV

DRUGpegylated liposomal doxorubicin hydrochloride

IV

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Response (Complete and Partial)Every 28 daysResponse Rate

Countries

United States

Participant flow

Participants by arm

ArmCount
Doxorubicin and Carboplatin
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1 carboplatin: IV pegylated liposomal doxorubicin hydrochloride: IV
9
Total9

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath1
Overall StudyDisease Progression6

Baseline characteristics

CharacteristicDoxorubicin and Carboplatin
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
3 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Age, Continuous63.9 years
STANDARD_DEVIATION 8.04
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
8 / 9
serious
Total, serious adverse events
2 / 9

Outcome results

Primary

Response (Complete and Partial)

Response Rate

Time frame: Every 28 days

Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026