Chemotherapeutic Agent ToxicityPhase 3PAM07NCT00662688
Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer
A Phase 3 study testing daltéparine and Chemotherapy at the investigator's discretion in people with Chemotherapeutic Agent Toxicity and Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chemotherapeutic Agent Toxicity, Pancreatic Cancer, Thromboembolism
- What is being tested?
- daltéparine and Chemotherapy at the investigator's discretion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesFrance
- Study dates
- Oct 2007to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Hospitalier de Meaux
Meaux, 77104
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
Montfermeil, 93370
Hopital Bichat - Claude Bernard
Paris, 75018
Hopital Saint Antoine
Paris, 75571
CHU Pitie-Salpetriere
Paris, 75651
Hopital Foch
Suresnes, 92151
About this study
Official title: Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas
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.
Read the 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.
- Being tested
- daltéparine, Chemotherapy at the investigator's discretion
- Keywords
- thromboembolism, chemotherapeutic agent toxicity, adenocarcinoma of the pancreas, stage IV pancreatic cancer, recurrent pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daltéparineDrug
Chemotherapy at the investigator's discretionDrug
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Active comparator | chemotherapy at investigator's discretion Receives: Drug: Chemotherapy at the investigator's discretion |
| dalteparin | Experimental | dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28. Receives: Drug: daltéparine; Drug: Chemotherapy at the investigator's discretion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolic events
number of thromboembolic events during anticoagulation treatment
Measured: during study treatment
Secondary outcomes (3)
Progression-free survival
Measured: at 6 months
Overall survival
Measured: at one year
Tolerance of regimens
Measured: each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: recruitment prematurely stopped due to a lack of eligible patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapeutic Agent ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoist Chibauldel, MD, Principal investigator, Hopital Saint Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662688
- Sponsor's protocol ID
- CDR0000593019
- Other IDs
- GERCOR-PAM07-D07-2, EUDRACT 2007-002115-59, EU-20837, PFIZER-GERCOR-PAM07-D07-2
- Acronym
- PAM07
- Status last verified
- Mar 2013
- First submitted
- 18 Apr 2008
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33337539
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas
- ClinicalTrials.gov ID
- NCT00662688
- Acronym / sponsor ID
- PAM07 / CDR0000593019
- Keywords
- thromboembolism, chemotherapeutic agent toxicity, adenocarcinoma of the pancreas, stage IV pancreatic cancer, recurrent pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment prematurely stopped due to a lack of eligible patients.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Active comparator | Drug: Chemotherapy at the investigator's discretionchemotherapy at investigator's discretion |
| dalteparin | Experimental | Drug: daltéparine, Drug: Chemotherapy at the investigator's discretiondalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| daltéparine | Drug | dalteparin |
| Chemotherapy at the investigator's discretion | Drug | chemotherapy, dalteparin |
Primary outcome
Thromboembolic events
Time frame: during study treatment
number of thromboembolic events during anticoagulation treatment
3 secondary outcomes
Progression-free survival
Time frame: at 6 months
Overall survival
Time frame: at one year
Tolerance of regimens
Time frame: each cycle
Results and safety
The study was stopped early (reason given: recruitment prematurely stopped due to a lack of eligible patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Derived from this study: PubMed 33337539Rutjes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoist Chibauldel, MD principal investigator
Hopital Saint Antoine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing daltéparine and Chemotherapy at the investigator's discretion in people with Chemotherapeutic Agent Toxicity and Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruitment prematurely stopped due to a lack of eligible patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolic events (time frame: during study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00662688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.