Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003135
First received: November 1, 1999
Last updated: April 29, 2009
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Drug: fluorouracil
Drug: pegylated liposomal doxorubicin hydrochloride
Procedure: hyperthermia treatment
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 34
Study Start Date: November 1997
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Evaluate tumor response and toxicity induced by fluorouracil and doxorubicin HCl liposome combined with mild systemic hyperthermia in patients with metastatic breast, ovarian, endometrial, or cervical cancer.

OUTLINE: This is a time-escalation study of systemic hyperthermia.

Patients receive fluorouracil IV continuously over 24 hours on days 1-5 and doxorubicin HCl liposome IV over 30 minutes on day 6. Beginning on day 7, patients receive heat applied for 6-24 hours (in 6-hour sequential treatments) using a mild hyperthermia-induction device. Treatment repeats every 4-5 weeks for a total of 4 courses. Patients who achieve less than a complete response but have no disease progression may receive additional courses of chemotherapy alone.

Cohorts of 5 patients receive escalating durations of hyperthermia until the recommended phase II duration is determined. The recommended phase II duration of hyperthermia is defined as the level preceding that at which 1 of 5 patients experiences measurable toxicity. (Phase I closed as of 9/28/01)

Patients are followed at 4 weeks and then every 6 months for 1 year.

PROJECTED ACCRUAL: A maximum of 34 patients will be accrued for this study within 48 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003135

Locations
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77225
Contact: Joan M.C. Bull, MD    713-500-6820    joan.m.bull@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Study Chair: Joan M.C. Bull, MD The University of Texas Health Science Center, Houston
  More Information

Additional Information:
No publications provided

Responsible Party: Joan M.C. Bull, University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier: NCT00003135     History of Changes
Other Study ID Numbers: CDR0000065903, UTHSC-MS-96205, NCI-V97-1356
Study First Received: November 1, 1999
Last Updated: April 29, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Fever
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Body Temperature Changes
Signs and Symptoms
Doxorubicin
Liposomal doxorubicin
Fluorouracil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014