Chemotherapy Compared to Biological Therapy in Treating Patients With Cancer of the Pancreas

NCT00003780 | Unknown Phase 2

• 2 other identifiers: CDR0000066912MEYER-AIT-PAN-201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known whether chemotherapy is more effective than biological therapy in treating patients with cancer of the pancreas. PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with biological therapy in treating patients who have cancer of the pancreas that cannot be surgically removed.

Conditions

Pancreatic Cancer

Keywords

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

Interventions

tumor infiltrating lymphocyte therapy BIOLOGICAL

gemcitabine hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven stage II, III, or IV pancreatic cancer that is unresectable No symptomatic third space fluid collection (e.g., ascites, pleural effusion) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 33% Hemoglobin at least 10.5 g/dL Hepatic: Bilirubin no greater than 3.0 mg/dL SGOT or SGPT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No history of myocardial infarction within past 3 months No congestive heart failure Other: HIV negative No other prior malignancy except basal cell skin cancer No persistent fever greater than 102 degrees F (39 degrees C) unless caused by the pancreatic cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy (e.g., interferons, interleukins) Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent systemic steroids Radiotherapy: No prior radiotherapy Surgery: At least 30 days since prior surgery Decompressive surgery and endoscopic stenting (including expandable wire stents) allowed to relieve symptoms of disease Other: At least 30 days since prior investigational therapy Palliative care to relieve symptoms of disease allowed, including pain management and celiac block by endoscopic ultrasonography or percutaneously

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

Sponsors & Collaborators

• Meyer Pharmaceuticals: lead

Study Sites (1)

Meyer Pharmaceuticals, LLC

Irvine, California, 92614, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Michael F. O'Neill

  Meyer Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 14, 2004
• Study Start: December 1, 1998
• Last Updated: December 19, 2013

Record last verified: 2007-05

Locations

US (1)