Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer

NCT00003769 | Completed Phase 2

• 3 other identifiers: 9710-07; T98-0046IUMC-9710-07NCI-T98-0046
• Study Type: interventional
• Target: N/A
• 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. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol followed by surgery in treating patients who have stage II or stage III pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas

Interventions

perillyl alcohol DRUG

surgical procedure PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage II or stage III pancreatic adenocarcinoma that is considered resectable Lesions should be amenable to surgery with curative intent Bidimensionally measurable or evaluable disease No evidence of metastatic disease No clinically detectable third space fluid collections (e.g., ascites or effusions) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.5 g/dL Hepatic: Bilirubin no greater than 4 times upper limit of normal (ULN) PTT no greater than 1.5 times control (unless on anticoagulants) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent serious systemic disorders incompatible with study No active infection No second primary malignancy, previously untreated with curative intent or presently active, that would preclude curative resection of the pancreas PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for pancreatic carcinoma Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for pancreatic carcinoma Surgery: See Disease Characteristics Other: At least 1 month since prior investigational agents At least 72 hours since prior anticoagulant therapy, cholesterol-lowering agents (e.g., lovastatin), high dosage vitamins, or antioxidants No concurrent anticoagulants except for the sole purpose of central line patency maintenance No other concurrent investigational agents

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

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

perillyl alcohol; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Patrick J. Loehrer, MD

  Indiana University Melvin and Bren Simon Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 31, 2004
• Study Start: February 1, 1999
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2001
• Last Updated: September 10, 2014

Record last verified: 2014-09

Locations

US (1)