Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic 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:
NCT00082862
First received: May 14, 2004
Last updated: February 10, 2012
Last verified: December 2008
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving low-dose interferon alfa on a metronomic (regularly timed) schedule may stop the growth of cancer by stopping blood flow to the tumor. Fever-range (above 101° F) whole-body hyperthermia kills tumor cells by heating them to several degrees above normal body temperature. Combining cisplatin, gemcitabine, and low-dose interferon alfa with fever-range whole-body hyperthermia may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin, gemcitabine, and metronomic low-dose interferon alfa together with fever-range whole-body hyperthermia works in treating patients with inoperable or metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Biological: recombinant interferon alfa
Drug: cisplatin
Drug: gemcitabine hydrochloride
Procedure: hyperthermia treatment
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of a Timing/Schedule Optimized Combined-Modality Regimen: Cisplatin + Metronomic Low-Dose Interferon-α (IFN-α) Followed by Gemcitabine HCl (GEMZAR) in Combination With Mild, Fever-Range Whole-Body Hyperthermia (FR-WBH) in Patients With Advanced, Inoperable Pancreatic Cancer

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 ]
  • Survival [ Designated as safety issue: No ]
  • Changes in quality of life [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conversion of inoperable tumors to operable [ Designated as safety issue: No ]
  • Changes in cellular and cytokine immune function [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2002
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine tumor response in patients with inoperable or metastatic pancreatic cancer treated with cisplatin, metronomic low-dose interferon alfa, gemcitabine, and fever-range whole-body hyperthermia.
  • Determine the toxicity of this regimen in these patients.
  • Determine the survival of patients treated with this regimen.
  • Determine changes in quality of life in patients treated with this regimen.

Secondary

  • Determine whether inoperable tumors convert to operable in patients treated with this regimen.
  • Determine changes in cellular and cytokine immune function in patients treated with this regimen.

OUTLINE: Patients are stratified according to disease stage (metastatic vs inoperable).

Patients receive cisplatin IV over 4-6 hours on day 1, interferon alfa subcutaneously once daily on days 1-28, and gemcitabine IV over 1 hour on days 3 and 10. Patients undergo fever-range whole-body hyperthermia (40°C over 6 hours) on day 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then before each treatment course.

PROJECTED ACCRUAL: A total of 18-48 patients (9-24 per stratum) will be accrued for this study within 4 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed pancreatic carcinoma

    • Inoperable or metastatic disease
  • Measurable lesion by physical examination, CT scan, or MRI

    • Carcinomatous hepatomegaly is considered measurable if a palpable liver edge clearly extends > 15 cm below the costal margin or xiphoid process
  • No known brain metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute granulocyte count ≥ 1,500/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin > 10.0 g/dL
  • Platelet count ≥ 90,000/mm^3
  • Bone marrow cellularity normal on bone marrow biopsy
  • No serious coagulopathy disorder

Hepatic

  • Bilirubin ≤ 2.5 mg/dL
  • SGPT and SGOT ≤ 2 times upper limit of normal
  • PT < 14 seconds
  • PTT < 35 seconds
  • INR < 1.5

Renal

  • Creatinine ≤ 1.8 mg/dL
  • Creatinine clearance ≥ 45 mL/min
  • Blood urea nitrogen ≤ 25 mg/dL

Cardiovascular

  • Adequate cardiovascular function as documented by the following:

    • History and physical examination
    • Stress exercise test (MUGA or echocardiogram) with resting blood pressure, heart rate, and LVEF that increase appropriately with exercise
    • LVEF ≥ 45%
  • No myocardial infarction within the past 6 months
  • No symptomatic coronary artery disease
  • No angina
  • No unstable blood pressure
  • No congestive heart failure
  • No significant arrhythmia
  • No conduction disturbance
  • No thromboembolic disease
  • No uncontrolled hypertension

Pulmonary

  • Complete pulmonary function studies with the following arterial blood gas values:

    • FEV_1 ≥ 70% of predicted
    • Arterial PO_2 ≥ 60 mm Hg on room air
    • PCO_2 appropriate
    • pH appropriate
  • No massive (≥ 30%) lung disease
  • DLCO > 50% of predicted

Other

  • No prior or concurrent seizures or other CNS disorders
  • No prior malignant hyperthermia after general anesthesia
  • No insulin-dependent diabetes mellitus
  • No significant emotional instability
  • No other medical problem that would preclude treatment with whole-body hyperthermia
  • HIV negative
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed

Chemotherapy

  • No prior cisplatin or gemcitabine

Endocrine therapy

  • No concurrent adrenal corticosteroids

Radiotherapy

  • More than 3 weeks since prior radiotherapy

Surgery

  • More than 6 days since prior major thoracic or abdominal surgery
  • Prior surgical resection of tumor with subsequent recurrence allowed

Other

  • No concurrent cardiac glycosides
  • No concurrent anti-angina or arrhythmia drugs
  • No concurrent thrombolytic agents
  • No concurrent anticoagulants
  • No concurrent 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: NCT00082862

Locations
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trials Office - University of Texas Health Science Ce    713-500-9500      
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Joan M.C. Bull, MD The University of Texas Health Science Center, Houston
  More Information

Additional Information:
Publications:
Responsible Party: Joan M.C. Bull, University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier: NCT00082862     History of Changes
Other Study ID Numbers: CDR0000360863, UTHSC-MS-02117
Study First Received: May 14, 2004
Last Updated: February 10, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Fever
Pancreatic Neoplasms
Body Temperature Changes
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
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

ClinicalTrials.gov processed this record on July 20, 2014