NCT02002195

Brief Summary

Elderly patients are generally underrepresented in the study populations of combination chemotherapy trials. In gastric cancer patients, oxaliplatin has shown a more favorable toxicity profile than cisplatin. A combination chemotherapy of 5-fluorouracil (5-FU) with oxaliplatin, mainly FOLFOX regimens, has been investigated in numerous phase II studies, using different doses and schedules, and has shown considerable antitumor activity. Insofar as toxicity is concerned, significant toxicities, including myelo-suppression and peripheral neuropathy, are a major issue for elderly patients. A modified FOLFOX regimen by omitting the administration of bolus 5-fluorouracil have shown a good profile of activity and tolerability in the elder population. This study evaluates the efficacy and safety of a modified FOLFOX (m FOLFOX) regimen for up to 8 cycles followed by capecitabine maintenance in elderly patients with metastatic gastric cancer and presenting associated disease(s)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

8 years

First QC Date

November 29, 2013

Last Update Submit

February 26, 2019

Conditions

Metastatic Gastric Cancer

Keywords

metastatic gastric cancer,elderly,folinic acid,fluorouracil,oxaliplatin,capecitabine,overall survival,progression free survival

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    progression-free survival

    6 months

Secondary Outcomes (4)

  • PFS on capecitabine maintenance

    6 months

  • overall survival

    12 months

  • number of patients with adverse events

    12 months

  • time to treatment failure

    12 months

Study Arms (1)

modified folfox

Oxaliplatin 85 mg/m2 in 2 hours intravenous infusion, + S-leucovorin 200 mg/m2, + 5-FU 2,400 mg/m2 as a 46 hours continuous infusion. The cycles are repeated every 2 weeks for a total of 8 cycle, if tumor response is stable disease, partial or complete response, then maintenance with Capecitabine 1,000 mg twice a day will be administered until disease progression, unacceptable toxicity or treatment refusal by the patient.

Drug: FOLFOXDrug: Capecitabine

Interventions

FOLFOXDRUG

Oxaliplatin 85 mg/m2 is given as a 2 hours intravenous infusion, concomitant to and S-leucovorin 200 mg/m2, and followed by 5-FU 2,400 mg/m2 as a 46 hours continuous infusion.

Also known as: oxaliplatin+leucovorin+ 5 Fluorouracil
modified folfox
CapecitabineDRUG

Capecitabine 1,000 mg twice a day will be administered until disease progression, unacceptable toxicity or treatment refusal by the patient.

Also known as: Xeloda
modified folfox

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients with recurrent or metastatic gastric cancer

You may qualify if:

  • Elderly patients (aged ≥65 years)
  • Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (GEJ)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (0-1 for patients aged ≥70 years, or with important comorbidity);
  • Measurable disease (revised RECIST) version 1.1. based on computed tomography
  • Adequate bone marrow, hepatic, and renal function, as evidenced by:
  • At least 4 weeks and recovery from effects of prior major surgery or radiation therapy
  • Ability to swallow an oral solid-dosage form of medication, including when a feeding tube is present
  • A negative serum pregnancy test within 7 days prior to accrual in women of childbearing potential (that is, all women except those who are post menopause for \> 1 year or who have a history of hysterectomy or surgical sterilization)
  • Agreement to use an effective form of contraception
  • Ability to comprehend and to comply with the requirements of the study
  • Estimated life expectancy ≥3 months
  • Adequate information and subsequent written informed consent

You may not qualify if:

  • Previous chemotherapy for metastatic/recurrent disease, except adjuvant chemotherapy completed at least 12 months before enrollment,
  • Previous treatment with oxaliplatin
  • Squamous cell gastric carcinoma
  • Bone-only metastatic disease significant gastrointestinal bleeding ,
  • Peripheral-neuropathy \> grade 2, History or presence of brain metastasis or leptomeningeal disease
  • Operable gastric or GEJ cancer
  • Herceptin (HER) 2 positive disease if the subject has not previously been treated with an anti -Herceptin (HER) 2 agent
  • Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the subject's usual number of bowel movements on at least 3 days within the 14 days prior to study entry
  • Nausea or vomiting for at least 3 consecutive days within the 14 days prior to study entry despite the administration of standard antiemetic therapy
  • Known malabsorptive disorder
  • Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)
  • Human immunodeficiency virus infection based on history of positive serology
  • Significant medical disease other than gastric cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study
  • Presence of neuropathy \> Grade 1
  • Prior radiation therapy to more than 25% of the bone marrow
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore

Pesaro, PU, 61122, Italy

RECRUITING

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio San Salvatore,

Pesaro, 61122, Italy

RECRUITING

Related Publications (4)

  • Catalano V, Bisonni R, Graziano F, Giordani P, Alessandroni P, Baldelli AM, Casadei V, Rossi D, Fedeli SL, D'Emidio S, Giustini L, Fiorentini G. A phase II study of modified FOLFOX as first-line chemotherapy for metastatic gastric cancer in elderly patients with associated diseases. Gastric Cancer. 2013 Jul;16(3):411-9. doi: 10.1007/s10120-012-0204-z. Epub 2012 Oct 11.

    PMID: 23065042BACKGROUND

  • Catalano V, Vincenzi B, Giordani P, Graziano F, Santini D, Baldelli AM, Alessandroni P, Schiavon G, Rossi D, Casadei V, D'Emidio S, Luzi Fedeli S, Tonini G, Fiorentini G. Sequential chemotherapy with cisplatin, leucovorin, and 5-fluorouracil followed by docetaxel in previously untreated patients with metastatic gastric cancer: a phase II study. Gastric Cancer. 2012 Oct;15(4):419-26. doi: 10.1007/s10120-011-0134-1. Epub 2012 Jan 12.

    PMID: 22237659BACKGROUND

  • De Vita F, Giuliani F, Silvestris N, Catalano G, Ciardiello F, Orditura M. Human epidermal growth factor receptor 2 (HER2) in gastric cancer: a new therapeutic target. Cancer Treat Rev. 2010 Nov;36 Suppl 3:S11-5. doi: 10.1016/S0305-7372(10)70014-1.

    PMID: 21129604BACKGROUND

  • Catalano V, Labianca R, Beretta GD, Gatta G, de Braud F, Van Cutsem E. Gastric cancer. Crit Rev Oncol Hematol. 2009 Aug;71(2):127-64. doi: 10.1016/j.critrevonc.2009.01.004. Epub 2009 Feb 20.

    PMID: 19230702BACKGROUND

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Folfox protocolCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Vincenzo Catalano, MD

    AORMN, U.O.C. Oncologia, Ospedale San Salvatore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Catalano, MD

CONTACT

0039072136vincenzo.catalano@ospedalimarchenord.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 29, 2013

First Posted

December 5, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2021

Study Completion

May 1, 2022

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

IT(2)