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Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer (PAM07)

Primary Purpose

Chemotherapeutic Agent Toxicity, Pancreatic Cancer, Thromboembolism

Status

Terminated

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

daltéparine

Chemotherapy at the investigator's discretion

About this trial

This is an interventional supportive care trial for Chemotherapeutic Agent Toxicity focused on measuring thromboembolism, chemotherapeutic agent toxicity, adenocarcinoma of the pancreas, stage IV pancreatic cancer, recurrent pancreatic cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
- Not amenable to treatment
- No localized or locally advanced disease
Measurable disease (metastatic or primary tumor) defined as ≥ 2 cm by CT scan or ≥ 1 cm by spiral CT scan or MRI
No progressive thrombo-embolic disease
No adenocarcinoma of the biliary tract or ampulla of Vater
No known CNS metastases

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Life expectancy > 12 weeks
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL
Alkaline phosphatase < 5 times normal
Bilirubin < 1.5 times normal
Creatinine < 1.5 times normal
Creatinine clearance < 30 mL/min
Pain controlled or stabilized via analgesic therapy
Affiliation with social security system
Not pregnant or nursing
No controlled or uncontrolled jaundice
No contraindication to study drugs
No cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
No serious cardiac and/or respiratory disease
No other cancer in the past 5 years except the following cancers, provided they have been completely resected:
- Skin cancer
- Localized melanoma
- Carcinoma in situ of the cervix
No history of thrombophilia
No history of heparin-induced thrombocytopenia
No uncontrolled or persistent hypercalcemia
No psychological, familial, social, and/or geographical condition that precludes participation in the study

PRIOR CONCURRENT THERAPY:

No prior hematologic therapy for metastatic disease
No prior abdominal radiotherapy
No concurrent corticosteroids as anti-emetic therapy
No other concurrent anticoagulation

Sites / Locations

Centre Hospitalier de Meaux
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
Hopital Bichat - Claude Bernard
Hopital Saint Antoine
CHU Pitie-Salpetriere
Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

chemotherapy

dalteparin

Arm Description

chemotherapy at investigator's discretion

dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28.

Outcomes

Primary Outcome Measures

Thromboembolic events

number of thromboembolic events during anticoagulation treatment

Secondary Outcome Measures

Progression-free survival

Overall survival

Tolerance of regimens

Full Information

NCT ID

NCT00662688

First Posted

April 18, 2008

Last Updated

March 12, 2013

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

1. Study Identification

Unique Protocol Identification Number

NCT00662688

Brief Title

Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer

Acronym

PAM07

Official Title

Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Terminated

Why Stopped

recruitment prematurely stopped due to a lack of eligible patients.

Study Start Date

October 2007 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, 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 chemotherapy. It is not yet known whether gemcitabine is more effective when given alone or together with dalteparin and/or capecitabine in treating patients with pancreatic cancer. PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots in patients with pancreatic cancer receiving treatment with different combinations of gemcitabine and capecitabine.

Detailed Description

OBJECTIVES: Primary To demonstrate that preventive anticoagulation with dalteparin reduces the number of thromboembolic events. To determine the number of thromboembolic events occurring with preventive anticoagulation. Secondary To determine survival without thrombotic event. To determine progression-free and overall survival. To determine time to response of tumor. To assess tolerance of these regimens. OUTLINE: This is a multicenter study. Patients are stratified according to participating center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 4 treatment arms. Arm A: Patients receive chemotherapy at investigator's discretion Arm B Patients receive chemotherapy at investigator's discretion and dalteparin In all arms, treatment repeats in the absence of disease progression or unacceptable toxicity. Blood and plasma samples are obtained at baseline and periodically during study. Blood is examined for biomarkers, resistance to activated protein C, and mutations (Leiden V factor, mutation G20210A, and the factor II gene). Thrombin generation and factors VIIa and VIII are assessed in plasma. After completion of study therapy, patients are followed periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapeutic Agent Toxicity, Pancreatic Cancer, Thromboembolism

Keywords

thromboembolism, chemotherapeutic agent toxicity, adenocarcinoma of the pancreas, stage IV pancreatic cancer, recurrent pancreatic cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

chemotherapy

Arm Type

Active Comparator

Arm Description

chemotherapy at investigator's discretion

Arm Title

dalteparin

Arm Type

Experimental

Arm Description

dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28.

Intervention Type

Drug

Intervention Name(s)

daltéparine

Intervention Type

Drug

Intervention Name(s)

Chemotherapy at the investigator's discretion

Primary Outcome Measure Information:

Title

Thromboembolic events

Description

number of thromboembolic events during anticoagulation treatment

Time Frame

during study treatment

Secondary Outcome Measure Information:

Title

Progression-free survival

Time Frame

at 6 months

Title

Overall survival

Time Frame

at one year

Title

Tolerance of regimens

Time Frame

each cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas Metastatic disease Not amenable to treatment No localized or locally advanced disease Measurable disease (metastatic or primary tumor) defined as ≥ 2 cm by CT scan or ≥ 1 cm by spiral CT scan or MRI No progressive thrombo-embolic disease No adenocarcinoma of the biliary tract or ampulla of Vater No known CNS metastases PATIENT CHARACTERISTICS: WHO performance status 0-2 Life expectancy > 12 weeks ANC ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Alkaline phosphatase < 5 times normal Bilirubin < 1.5 times normal Creatinine < 1.5 times normal Creatinine clearance < 30 mL/min Pain controlled or stabilized via analgesic therapy Affiliation with social security system Not pregnant or nursing No controlled or uncontrolled jaundice No contraindication to study drugs No cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months No serious cardiac and/or respiratory disease No other cancer in the past 5 years except the following cancers, provided they have been completely resected: Skin cancer Localized melanoma Carcinoma in situ of the cervix No history of thrombophilia No history of heparin-induced thrombocytopenia No uncontrolled or persistent hypercalcemia No psychological, familial, social, and/or geographical condition that precludes participation in the study PRIOR CONCURRENT THERAPY: No prior hematologic therapy for metastatic disease No prior abdominal radiotherapy No concurrent corticosteroids as anti-emetic therapy No other concurrent anticoagulation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benoist Chibauldel, MD

Organizational Affiliation

Hopital Saint Antoine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier de Meaux

City

Meaux

ZIP/Postal Code

77104

Country

France

Facility Name

Centre Hospitalier Intercommunal Le Raincy - Montfermeil

City

Montfermeil

ZIP/Postal Code

93370

Country

France

Facility Name

Hopital Bichat - Claude Bernard

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

Hopital Saint Antoine

City

Paris

ZIP/Postal Code

75571

Country

France

Facility Name

CHU Pitie-Salpetriere

City

Paris

ZIP/Postal Code

75651

Country

France

Facility Name

Hopital Foch

City

Suresnes

ZIP/Postal Code

92151

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

33337539

Citation

Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

Results Reference

derived

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Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer

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