Cisplatin, Gemcitabine, Interferon Alfa, and Hyperthermia in Treating Patients With Advanced Cancer - Full Text View

Sponsor:	The University of Texas Health Science Center, Houston
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004063

Purpose

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.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Biological: recombinant interferon alfa Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: hyperthermia treatment	Phase I Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fever

Drug Information available for: Cisplatin Interferon alfa-2a Gemcitabine Gemcitabine hydrochloride Interferon alfa-n1 Interferons

U.S. FDA Resources

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

Primary Outcome Measures:

Response duration [ Designated as safety issue: No ]
Duration of stable disease [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Time to response [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 1999
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

At least 12 weeks

Hematopoietic:

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

Hepatic:

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)

Renal:

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

Cardiovascular:

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

Pulmonary:

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

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Prior chemotherapy allowed

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

At least 6 days since major thoracic or abdominal surgery

Other:

No concurrent cardiac glycosides, antiangina drugs, arrhythmia drugs, anticoagulants, thrombolytic agents, adrenal corticosteroids, or aspirin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004063

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Joan M.C. Bull, University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier:	NCT00004063 History of Changes
Obsolete Identifiers:	NCT00005929
Other Study ID Numbers:	CDR0000067264, UTHSC-MS-99116, NCI-V99-1561
Study First Received:	December 10, 1999
Last Updated:	April 29, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Fever
Body Temperature Changes
Signs and Symptoms
Interferon-alpha
Interferon Alfa-2a
Interferons
Gemcitabine
Cisplatin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors

Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 12, 2012