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Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients (SOCRATE)

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ClinicalTrials.gov Identifier: NCT03760822
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Brief Summary:

The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed.

The co-primary endpoints are the following:

  • Six months survival rate
  • Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future

Condition or disease Intervention/treatment Phase
Stomach Cancer Stomach Neoplasm Gastric Cancer Gastroesophageal Junction Adenocarcinoma Drug: Ramucirumab Drug: Paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ramucirumab
IV ramucirumab at 8 mg/kg on D1 and D15
Drug: Ramucirumab
IV ramucirumab at 8 mg/kg on D1 and D15
Other Name: Cyramza

Active Comparator: Ramucirumab + Paclitaxel
IV ramucirumab at 8 mg/kg on D1 and D15 IV paclitaxel at 80 mg/m² on D1, D8 and D15
Drug: Ramucirumab
IV ramucirumab at 8 mg/kg on D1 and D15
Other Name: Cyramza

Drug: Paclitaxel
IV paclitaxel at 80 mg/m² on D1, D8 and D15
Other Name: Abraxane




Primary Outcome Measures :
  1. Patient survival rate at 6 months [ Time Frame: at 6 months ]
    Rate of patients alive

  2. Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: worries about the future [ Time Frame: at 4 months ]
    Derived from items 38, 39 and 40 of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score

  3. Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: mobility [ Time Frame: at 4 months ]
    Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.

  4. Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: illness burden [ Time Frame: at 4 months ]
    Derived from items 43 and 44of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score


Secondary Outcome Measures :
  1. Total score of global health status [ Time Frame: at 4 months ]
    Score defined is based on item 30 in the EORTC QLQC30 questionnaire

  2. Overall survival [ Time Frame: 6 months ]
    Defined as time to death (whatever cause is) or for patients alive time to last news.

  3. Toxicity (NCI CTC 4.0) [ Time Frame: 6 months ]
    Defined by all the toxicities collected at each cycle

  4. Time to treatment failure [ Time Frame: 6 months ]
    Time between randomization and disease progression, treatment interruption or death

  5. Progression-free survival [ Time Frame: 6 months ]
    Progression-free survival (clinical and/or radiological) determined by the investigator based on RECIST V1.1

  6. Tumor response rate [ Time Frame: at 2 and 4 months ]
    According to RECIST criteria (if disease is measurable) determined by the investigator



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, whatever HER2 status
  • Aged ≥ 70 years
  • WHO < 2
  • Estimated life expectancy > 3 months
  • Measurable or non-measurable disease according to RECIST 1.1 criteria
  • Documented progression during first-line fluoropyrimidine- and platinum- or irinotecan containing chemotherapy (with or without anthracycline), or during the 4 months following the last cycle of such chemotherapy administered for metastatic or locally advanced disease, or during the 6 months following the last dose of adjuvant therapy containing fluoropyrimidine and platinium (treatment by immunotherapy is allowed)
  • Adequate hepatic, renal and hematologic function:

    • ANC ≥ 1 500 / mm3, platelets ≥ 100 000 / mm3, hemoglobin ≥ 9 g/dL
    • Blood creatinine ≤ 1.5 x ULN and creatinine clearance (MDRD formula) ≥ 40 mL/min
    • Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN (≤ 5 x ULN if hepatic metastasis)
    • INR ≤ 1.5 or INR ≤ 3 for patients taking AVK and PTT ≤ 5 seconds above the ULN
    • Dipstick proteinuria ≤ 1+ or 24 hour proteinuria < 1 g in total
  • EORTC QLQ-C30 + QLQ-ELD14, completed and faxed to the Randomization, Management and Analysis Center of the FFCD
  • IADL geriatric questionnaire, completed and faxed to Randomization Management and Analysis Center of FFCD
  • Signed informed consent

Exclusion Criteria:

  • Known cerebral metastasis
  • Prior treatment by taxanes
  • Prior treatment with an antiangiogenic
  • Neuropathy of grade ≥ 2 (NCI-CTCAE 4.0)
  • Unresolved partial or total bowel obstruction, inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or extensive gastrointestinal (GI) resection combined with chronic diarrhea
  • GI perforation and/or fistulae in the 6 months preceding randomization.
  • GI bleeding within the last 3 months of grade ≥ 3 (NCI-CTCAE 4.0)
  • Chronic use of antiplatelet drugs (including aspirin, but a daily intake of ≤ 325 mg/day is accepted), non-steroidal anti-inflammatory drugs (ibuprofen, naproxen), dipyridamole, clopidogrel or similar agents
  • Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack) in the 6 months preceding randomization
  • A life-threatening episode of pulmonary embolism in the 6 months preceding randomization
  • Deep-vein thrombosis, pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant" during the 3 months prior to first dose of protocol therapy
  • Uncompensated congestive heart failure or uncontrolled arrhythmia
  • Uncontrolled hypertension (≥ 140/90 mm Hg for > 4 weeks) despite properly observed antihypertensive therapy
  • Cirrhosis at a level of Chilg-Pugh B or C; or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
  • Serious or unhealed wound, peptic ulcer or fracture within 28 days of randomization
  • Radiotherapy or major surgery within 28 days of prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior the first dose of protocol therapy
  • Known allergy to paclitaxel or ramucirumab
  • Another concomitant cancer or a history of cancer in the last 5 years, except cervical carcinoma in situ, cutaneous basal-cell or squamous-cell carcinoma, or any other carcinoma in situ deemed to be successfully treated
  • Lack of effective contraception in patients (man and/or women) of childbearing age, and/or their
  • Persons deprived of liberty or under supervision
  • Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons

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): NCT03760822


Contacts
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Contact: Flore GEILLON +33 3 80 39 34 83 flore.geillon@u-bourgogne.fr
Contact: Marie MOREAU +33 3 80 39 34 04 marie.moreau@u-bourgogne.fr

Locations
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France
Hopitaux civils de Colmar Recruiting
Colmar, France
Contact: Gilles BREYSACHER, Dr         
Clinique privée - CENTRE CARIO Recruiting
Plérin, France
Contact: MARTIN-BABAU, Dr         
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Eli Lilly and Company
Investigators
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Principal Investigator: Astrid Lièvre, Pr CHU de Pontchaillou - Rennes

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Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT03760822     History of Changes
Other Study ID Numbers: PRODIGE 55 - SOCRATE
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Federation Francophone de Cancerologie Digestive:
ramucirumab
elderly patient
second line therapy
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Ramucirumab
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs