Recruiting
Phase 2

Cisplatin, Gemcitabine, Interferon

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT00082862

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

recombinant interferon alfa

cisplatin

gemcitabine hydrochloride

hyperthermia treatment

Study Details

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

Study ID

NCT00082862

Start date

Jul, 2002

Status verified date

Dec, 2008

Primary completion date

Nov, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

recombinant interferon alfa

cisplatin

gemcitabine hydrochloride

hyperthermia treatment

Primary outcome measure

  • Tumor response [ Time Frame: undefined ]
  • Toxicity [ Time Frame: undefined ]
  • Survival [ Time Frame: undefined ]
  • Changes in quality of life [ Time Frame: undefined ]

Central Contacts and Locations

Locations

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Clinical Trials Office - University of Texas Health Science Ce

713-500-9500

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Feb 13, 2012

Last verified

Dec, 2008

Keywords

  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2012-02-13.