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Cisplatin, Gemcitabine, Interferon Alfa, and Hyperthermia in Treating Patients With Advanced Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: January 27, 2003
Last Update Posted: April 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
December 10, 1999
January 27, 2003
April 30, 2009
August 1999
November 2011   (Final data collection date for primary outcome measure)
  • Response duration
  • Duration of stable disease
  • Overall survival
  • Progression-free survival
  • Time to response
Not Provided
Complete list of historical versions of study NCT00004063 on ClinicalTrials.gov Archive Site
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Cisplatin, Gemcitabine, Interferon Alfa, and Hyperthermia in Treating Patients With Advanced Cancer
A Phase I-II Clinical Trial of Cisplatin (Platinol) Followed by Gemcitabine HCl (Gemzar) in Combination With Mild, Fever-Range Whole Body Hyperthermia (LL-WBH) at 40C in Patients With Advanced Malignancies

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy and interferon alfa may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects of cisplatin, gemcitabine, interferon alfa, and whole-body hyperthermia and how well they work in treating patients with metastatic, recurrent, or refractory cancer.


  • Determine the toxicity and tumor response in patients with metastatic, recurrent, or refractory malignancies treated with cisplatin, gemcitabine, interferon alfa, and long-duration, low temperature whole body hyperthermia (LL-WBH).

OUTLINE: This is a dose escalation study of cisplatin.

  • Phase I and II: Patients receive gemcitabine IV over 30 minutes on day 1 and 8. Patients receive cisplatin IV over 6 hours on day 15, followed by subcutaneous interferon alfa on days 16 and 17. Patients undergo long-duration, low temperature whole body hyperthermia over 6 hours plus gemcitabine over 30 minutes on day 17. Courses repeat every 5 weeks in the absence of disease progression or unacceptable toxicity.
  • Phase I: Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity. The MTD of cisplatin is used for phase II study.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Phase 1
Phase 2
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Biological: recombinant interferon alfa
  • Drug: cisplatin
  • Drug: gemcitabine hydrochloride
  • Procedure: hyperthermia treatment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
Not Provided
November 2011   (Final data collection date for primary outcome measure)


  • Histologically confirmed metastatic, recurrent, or refractory carcinoma
  • Measurable disease by CT, MRI, or physical examination
  • No brain metastases or other CNS disorders



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 12 weeks


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 90,000/mm^3
  • Bone marrow cellularity normal on bone marrow biopsy
  • No coagulopathy disorder


  • Bilirubin no greater than 2.0 mg/dL
  • SGOT no greater than 2 times upper limit of normal
  • PT less than 14 seconds
  • PTT less than 35 seconds
  • No inadequate liver function (no greater than 20% involvement)


  • Creatinine no greater than 1.8 mg/dL
  • Creatinine clearance at least 45 mL/min
  • BUN no greater than 25 mg/dL


  • Adequate cardiac function documented by history, physical exam, or stress exercise test (MUGA or ECHO) with resting blood pressure and heart rate increasing appropriately with exercise
  • LVEF at least 45%
  • No prior myocardial infarction
  • No symptomatic coronary artery disease
  • No angina
  • No significant arrhythmia
  • No uncontrolled hypertension
  • No thromboembolic disease


  • FEV_1 at least 70% of predicted
  • Arterial PO_2 at least 60 mmHg on room air
  • No massive (greater than 30% involvement) lung disease
  • DLCO greater than 50% of predicted


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No seizure disorders
  • No significant emotional instability
  • No history of malignant hyperthermia following general anesthesia
  • No other concurrent medical illness that would prevent compliance


Biologic therapy:

  • Not specified


  • Prior chemotherapy allowed

Endocrine therapy:

  • Not specified


  • Not specified


  • At least 6 days since major thoracic or abdominal surgery


  • No concurrent cardiac glycosides, antiangina drugs, arrhythmia drugs, anticoagulants, thrombolytic agents, adrenal corticosteroids, or aspirin
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Joan M.C. Bull, University of Texas Health Science Center at Houston
The University of Texas Health Science Center, Houston
Not Provided
Study Chair: Joan M.C. Bull, MD The University of Texas Health Science Center, Houston
National Cancer Institute (NCI)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP