NCT00003135

Brief Summary

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hyperthermia may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving fluorouracil and liposomal doxorubicin together with systemic hyperthermia works in treating patients with metastatic breast, ovarian, endometrial, or cervical cancer.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

April 30, 2009

Status Verified

December 1, 2008

Enrollment Period

11.8 years

First QC Date

November 1, 1999

Last Update Submit

April 29, 2009

Conditions

Breast CancerCervical CancerEndometrial CancerOvarian Cancer

Keywords

stage IV breast cancerrecurrent breast cancerrecurrent cervical cancerstage IVB cervical cancerstage IVA cervical cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerstage IV endometrial carcinomarecurrent endometrial carcinomastage IV ovarian germ cell tumorrecurrent ovarian germ cell tumormale breast cancer

Outcome Measures

Primary Outcomes (2)

  • Tumor response

  • Toxicity

Interventions

fluorouracilDRUG
pegylated liposomal doxorubicin hydrochlorideDRUG
hyperthermia treatmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast, ovarian, endometrial, or cervical carcinoma * Measurable and evaluable disease * No brain metastases * No hepatic involvement greater than 80% * No lung involvement greater than 30% * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Not specified Menopausal status: * Not specified Performance status: * Zubrod 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute granulocyte count greater than 1,500/mm\^3 * Platelet count greater than 90,000/mm\^3 * Normal bone marrow cellularity on bone marrow biopsy * Thrombin time less than 17 sec * Fibrinogen greater than 200 mg/dL * FSP less than 40 * No coagulopathy Hepatic: * Bilirubin less than 2.0 mg/dL * SGPT less than 2 times normal * PT less than 14 sec * PTT less than 35 sec Renal: * BUN less than 25 mg/dL * Creatinine clearance at least 45 mL/min Cardiovascular: * Normal cardiovascular system * Resting ventricular ejection fraction greater than 40% * No prior myocardial infarction * No symptomatic coronary artery disease * No unstable blood pressure * No thromboembolic disease Neurologic: * No seizures or other CNS disorders * Negative computerized tomographic scan of brain Pulmonary: * FEV\_1 greater than 70% of predicted * Arterial pressure of oxygen greater than 60 mmHg on room air with appropriate pressure of carbon dioxide and pH values * No history of cardiopulmonary or respiratory disease Other: * No other serious concurrent medical illness * No diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy allowed Endocrine therapy: * No adrenal corticosteroids Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent cardiac glycosides, antianginal therapy, or antiarrhythmics * No concurrent vasodilators, anticoagulants, thrombolytic agents, or aspirin

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

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77225, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian EpithelialBreast Neoplasms, Male

Interventions

FluorouracilDiathermy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHyperthermia, InducedTherapeutics

Study Officials

  • Joan M.C. Bull, MD

    The University of Texas Health Science Center, Houston

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

November 1, 1997

Primary Completion

September 1, 2009

Last Updated

April 30, 2009

Record last verified: 2008-12

Locations

US(1)