Recruiting
Phase 2

Whole Body Hyperthermia & Chemotherapy

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT00003135

Conditions

Breast Cancer

Cervical Cancer

Endometrial Cancer

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

fluorouracil

pegylated liposomal doxorubicin hydrochloride

hyperthermia treatment

Study Details

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.

Conditions

Breast Cancer

Cervical Cancer

Endometrial Cancer

Ovarian Cancer

Study ID

NCT00003135

Start date

Nov, 1997

Status verified date

Dec, 2008

Primary completion date

Sep, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

fluorouracil

pegylated liposomal doxorubicin hydrochloride

hyperthermia treatment

Primary outcome measure

  • Tumor response [ Time Frame: undefined ]
  • Toxicity [ Time Frame: undefined ]

Central Contacts and Locations

Locations

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77225

Contacts

Joan M.C. Bull, MD

713-500-6820joan.m.bull@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Apr 30, 2009

Last verified

Dec, 2008

Keywords

  • stage IV breast cancer
  • recurrent breast cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • stage IVA cervical cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • stage IV ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • male breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2009-04-30.