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

NCT00470067 | Terminated Phase 2 Results DMC

• 2 other identifiers: CDR0000543389RPCI-I-68005
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma

Outcome Measures

Primary Outcomes (1)

• Response (Complete and Partial)

  Response Rate

  Every 28 days

Study Arms (1)

Doxorubicin and carboplatin

EXPERIMENTAL

Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1

Drug: carboplatin; Drug: pegylated liposomal doxorubicin hydrochloride

Interventions

carboplatin DRUG

IV

Doxorubicin and carboplatin

pegylated liposomal doxorubicin hydrochloride DRUG

IV

Doxorubicin and carboplatin

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Carboplatin

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)

Coordination Complexes; Organic Chemicals

Limitations and Caveats

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

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Shashikant B. Lele, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2009
• Last Updated: August 22, 2014
• Results First Posted: August 22, 2014

Record last verified: 2014-08

Locations

US (1)