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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response

Safety Issue:

No

Principal Investigator

Joan M.C. Bull, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Health Science Center, Houston

Authority:

Unspecified

Study ID:

CDR0000360863

NCT ID:

NCT00082862

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Fever
  • Pancreatic Neoplasms

Name

Location

University of Texas Health Science Center at HoustonHouston, Texas  77225