Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may help prevent blood clots in patients being treated with gemcitabine for unresectable or metastatic pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without dalteparin in treating patients who have unresectable or metastatic pancreatic cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gary Morrow
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dalteparin; Gemcitabine; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma of the pancreas that is considered ineligible for curative resection

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Eastern Cooperative Oncology Group 0-2

Life expectancy:

• Not specified

Hematopoietic:

• White Blood Cell count greater than 3,500/mm^3

• Platelet count greater than 100,000/mm^3

• No clinically significant bleeding disorder

• No prior heparin-induced thrombocytopenia

Hepatic:

• Bilirubin less than 2.0 mg/dL

• aspartate aminotransferase less than 3 times normal

Renal:

• Creatinine less than 2.0 mg/dL

Cardiovascular:

• No prior hemorrhagic stroke

• No uncontrolled hypertension (sustained blood pressure greater than 200 mm Hg systolic or 110 mm Hg diastolic)

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other active malignancy

• No gastrointestinal bleeding within the past 30 days

• No contraindications to anticoagulation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for metastatic disease

• Prior adjuvant chemotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• Prior surgical resection allowed

• At least 4 weeks since prior surgery with non-curative intent and recovered

• More than 30 days since prior neurologic or ophthalmologic surgery

Other:

• At least 2 weeks since prior low-molecular-weight heparin

• More than 30 days since prior experimental therapeutic agent

• No concurrent heparin or warfarin for pre-existing condition