Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer

NCT00082862 | Unknown Phase 2

• 2 other identifiers: CDR0000360863UTHSC-MS-02117
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

stage II pancreatic cancer; stage III pancreatic cancer; recurrent pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (4)

• Tumor response

• Toxicity

• Survival

• Changes in quality of life

Secondary Outcomes (2)

• Conversion of inoperable tumors to operable

• Changes in cellular and cytokine immune function

Interventions

recombinant interferon alfa BIOLOGICAL

cisplatin DRUG

gemcitabine hydrochloride DRUG

hyperthermia treatment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• Bull JM, Scott GL, Strebel FR, Nagle VL, Oliver D, Redwine M, Rowe RW, Ahn CW, Koch SM. Fever-range whole-body thermal therapy combined with cisplatin, gemcitabine, and daily interferon-alpha: a description of a phase I-II protocol. Int J Hyperthermia. 2008 Dec;24(8):649-62. doi: 10.1080/02656730802104740.

  PMID: 18608594 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Interferon-alpha; Cisplatin; Gemcitabine; Diathermy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Hyperthermia, Induced; Therapeutics

Study Officials

• Joan M.C. Bull, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2004
• First Posted: May 19, 2004
• Study Start: July 1, 2002
• Primary Completion: November 1, 2012
• Last Updated: February 13, 2012

Record last verified: 2008-12

Locations

US (1)