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Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer (MOAnab1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174887
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:

The prognostic of metastatic pancreatic adenocarcinoma is dismal and the treatment gold standard since the end of the 90s' is gemcitabine; unfortunately all trials testing combinations of gemcitabine with chemotherapeutic agents or targeted agents had failed to demonstrate any superiority over gemcitabine monotherapy.

In a recently published phase I/II study of combination of gemcitabine plus nab-paclitaxel in patients with metastatic pancreatic adenocarcinoma (PAC), the combination gave an impressive response rate of 48% (Gemcitabine 1g/m² and nab-paclitaxel 125 mg/m² once a week for 3 weeks, every 4 weeks). The safety profile was correct (fatigue, sensory neuropathy, nausea, haematological side effects). This efficacy can be related to an improvement of gemcitabine delivery to the tumor bed, as shown on preclinical studies: the response rate in xenografts was better with the combination; this improvement was associated with an increase of intratumoral gemcitabine concentration in mice receiving the combination when compared to mice receiving gemcitabine alone. This might be associated to modifications of peritumoral stroma with reduction of stromal content and increase in dilated vessels.

The aim of this study is to evaluate if the combination of nab-paclitaxel plus gemcitabine induces a modification in vascularization of pancreatic adenocarcinoma on the primary tumor and of liver metastases after 2 cycles of treatment by comparison to baseline.


Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Drug: Nab-paclitaxel + Gemcitabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Unicentric, Open Label, Mechanism of Action Trial, on the Biological Effect of Nab-paclitaxel Combined to Gemcitabine, in Patients With Metastatic Pancreatic Adenocarcinoma
Actual Study Start Date : September 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: Nab-paclitaxel + Gemcitabine
Gemcitabine 1 g/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days in combination with Nab-paclitaxel 125 mg/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days The patients will receive 2 cycles of treatment every 28 days
Drug: Nab-paclitaxel + Gemcitabine

Gemcitabine 1 g/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days in combination with Nab-paclitaxel 125 mg/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days

The patients will receive 2 cycles of treatment every 28 days:





Primary Outcome Measures :
  1. Vascularization parameters of pancreatic carcinoma [ Time Frame: 2 months ]

    Vascularization parameters of pancreatic carcinoma:

    • on the primary tumor assessed by contrast-enhanced harmonic endoscopic ultrasonography (EUS)
    • and on liver metastases assessed by contrast enhanced ultrasonography (ceUS)


Secondary Outcome Measures :
  1. Stiffness [ Time Frame: 2 months ]
    Stiffness will be assessed in the primary tumor using ratio-elastography

  2. Density [ Time Frame: 2 months ]
    Density will be assessed in liver metastases on CTscan using density measurement before injection of contrast agent and after injection during the portal phase (80 sec post IV)

  3. Safety [ Time Frame: 2 months ]
    Adverse events of the treatment will be evaluated according to the Common Toxicity Criteria for Adverse Events (CTCAE version 4.03)

  4. Response rate [ Time Frame: 2 months ]
    Response rate will be evaluated according to RECIST V1.1 and CHOI criteria



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. Suspicion of pancreatic adenocarcinoma
  3. With liver measurable metastases
  4. Primary tumor non resected
  5. First line systemic treatment
  6. Correct haematological parameters
  7. Adequate Blood chemistry levels
  8. Life expectancy ≥ 2 months
  9. PS: 0 - 2
  10. Affiliation to French National social security or beneficiary
  11. Signed informed consent.
  12. Female patients must be surgically sterile, or be postmenopausal, or must commit to using reliable and appropriate methods of contraception during the study and during at least three months after the end of study treatment. All female patients with reproductive potential must have a negative pregnancy test (β HCG) within 72 hours prior to starting abraxane treatment. Breastfeeding is not allowed. Male patients must agree to use effective contraception in addition to having their partner use a contraceptive method as well during the trial and during at least six months after the end of the study treatment,

Exclusion Criteria:

  1. Previous radiotherapy of the tumor
  2. Patient has only locally advanced disease.
  3. Previous treatment with gemcitabine
  4. Active infection or severe concomitant disease
  5. Serious Peripheral neuropathy
  6. Known hypersensitivity or contraindication to any component of study drug formulation.
  7. Pregnant or breastfeeding women
  8. Other experimental treatment
  9. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
  10. Known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
  11. Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity
  12. Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary, Hypersensitivity pneumonitis or multiple allergies
  13. Patient uses Coumadin
  14. Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to complete the study or sign the consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174887


Locations
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France
Institut Paoli-Calmettes
Marseille, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Jean-Luc RAOUL, MD Institut Paoli-Calmettes
Additional Information:
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT02174887    
Other Study ID Numbers: MOAnab1-IPC 2012-010
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Keywords provided by Institut Paoli-Calmettes:
pancreatic adenocarcinoma
liver metastases
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs