Gemcitabine With or Without Dalteparin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hull and East Yorkshire Hospitals NHS Trust
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00462852
First received: April 18, 2007
Last updated: August 5, 2011
Last verified: April 2007
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Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with gemcitabine for pancreatic cancer.
PURPOSE: This randomized phase II trial is studying how well gemcitabine works with or without dalteparin in treating patients with locally advanced or metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer Thromboembolism |
Drug: dalteparin Drug: gemcitabine hydrochloride Other: diagnostic laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized Study of Chemo-Anticoagulation (Gemcitabine-Dalteparin) Versus Chemotherapy Alone (Gemcitabine) for Locally Advanced and Metastatic Pancreatic Adenocarcinoma [FRAGEM] |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Incidence of venous thromboembolism reduction [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Early survival benefit [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Effect of drug combination on serological markers of thromboangiogenesis [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2003 |
OBJECTIVES:
Primary
- Compare the incidence of venous thromboembolism in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and dalteparin versus gemcitabine hydrochloride alone.
Secondary
- Compare the survival benefit, in terms of increased (from 70% to 85%) survival at 12 weeks, of patients treated with these regimens.
- Compare the toxicity of these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the time to disease progression in patients treated with these regimens.
- Determine the effect of gemcitabine hydrochloride and dalteparin on serological markers of thromboangiogenesis.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to disease progression (locally advanced vs metastatic) and Karnofsky performance status (≥ 80% vs < 80%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 and 9-11.
- Arm II: Patients receive low molecular weight dalteparin subcutaneously once daily in weeks 1-12. Patients also receive gemcitabine hydrochloride as in arm I.
Blood samples are acquired at baseline for analysis of circulating tissue factor and vascular endothelial growth factor.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the pancreas
- Patients with clinical 'high probability' of pancreatic cancer and biopsy suggestive but not diagnostic of pancreatic cancer may be eligible based on review by the principal investigator
- Measurable or evaluable disease
- No clinical evidence of active venous thromboembolism
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 60-100% OR WHO PS 0-2
- Life expectancy > 12 weeks
- Absolute neutrophil count > 2,000/mm³
- WBC > 3,000/mm³
- Platelet count > 100,000/mm³
- Creatinine clearance > 50 mL/min
- INR ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN (stent allowed)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No cerebrovascular accident within the past 6 months
No obvious contraindication to anticoagulation, including the following:
- Bleeding diathesis
- Active peptic ulcer
- Ulcerating cancer into duodenum
- No history of other advanced malignancy
- No gross hematuria
- No melaena or gross evidence of gastrointestinal bleeding (other than piles)
- No requirement for a central line
- No other significant medial or psychiatric illness that, in the opinion of the investigator, would preclude study participation
PRIOR CONCURRENT THERAPY:
- No prior gemcitabine hydrochloride-containing treatment
- No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or experimental medications
- No other concurrent specific anticancer therapy as a result of disease progression
- No concurrent caval filter device
- No other concurrent anticoagulants for venous thromboembolism or other reasons (e.g., atrial fibrillation)
- No concurrent acetylsalicylic acid (> 75 mg) as an antiplatelet drug for a preexisting cardiovascular condition
- No concurrent clopidogrel bisulfate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462852
Locations
| United Kingdom | |
| Princess Royal Hospital at Hull and East Yorkshire NHS Trust | Recruiting |
| Hull, England, United Kingdom, HU8 9HE | |
| Contact: Anthony Maraveyas 44-148-467-6703 | |
| Royal Lancaster Infirmary | Recruiting |
| Lancaster, England, United Kingdom, LA1 4RP | |
| Contact: David Fyfe, MD 44-152-458-3404 | |
| Saint Bartholomew's Hospital | Recruiting |
| London, England, United Kingdom, EC1A 7BE | |
| Contact: David Propper, MD 44-207-601-7460 d.j.propper@qmul.ac.uk | |
| St. George's Hospital | Recruiting |
| London, England, United Kingdom, SW17 0QT | |
| Contact: Tim Benepal, MD 44-208-725-2995 | |
| Maidstone Hospital | Recruiting |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Contact: Justin Waters, MD 44-162-222-5149 | |
| Nottingham City Hospital | Recruiting |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Contact: Sarah Ayres, MD 44-115-969-1169 | |
| Scarborough General Hospital | Recruiting |
| Scarborough, England, United Kingdom, YO12 6QL | |
| Contact: Contact Person 44-0172-334-2175 | |
| Scunthorpe General Hospital | Recruiting |
| Scunthorpe, England, United Kingdom, DN15 7BH | |
| Contact: Contact Person 44-1724-282-282 | |
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
| Study Chair: | Anthony Maraveyas | Hull and East Yorkshire Hospitals NHS Trust |
More Information
Additional Information:
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00462852 History of Changes |
| Other Study ID Numbers: | CDR0000540180, PRH-HCTU-FRAGEM, PRH-HCTU-FRAGEM-V-12.1, CTA-MF8000/13558, EU-20721, LILLY-PRH-HCTU-FRAGEM, ISRCTN76464767 |
| Study First Received: | April 18, 2007 |
| Last Updated: | August 5, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
thromboembolism stage III pancreatic cancer stage IV pancreatic cancer |
adenocarcinoma of the pancreas recurrent pancreatic cancer stage II pancreatic cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Thromboembolism Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Thrombosis Dalteparin Heparin, Low-Molecular-Weight Gemcitabine Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 22, 2013