Modified Folinic Acid-Fluorouracil-Oxaliplatin Regimen + Capecitabine for Elderly With Metastatic Gastric Cancer

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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)

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Group of Endovascular Oncology
• Treatments: Capecitabine; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

1. Elderly patients (aged ≥65 years)

2. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (GEJ)

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (0-1 for patients aged ≥70 years, or with important comorbidity);

4. Measurable disease (revised RECIST) version 1.1. based on computed tomography

5. Adequate bone marrow, hepatic, and renal function, as evidenced by:

6. At least 4 weeks and recovery from effects of prior major surgery or radiation therapy

7. Ability to swallow an oral solid-dosage form of medication, including when a feeding tube is present

8. 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)

9. Agreement to use an effective form of contraception

10. Ability to comprehend and to comply with the requirements of the study

11. Estimated life expectancy ≥3 months

12. Adequate information and subsequent written informed consent

Exclusion Criteria:

1. Previous chemotherapy for metastatic/recurrent disease, except adjuvant chemotherapy completed at least 12 months before enrollment,

2. Previous treatment with oxaliplatin

3. Squamous cell gastric carcinoma

4. Bone-only metastatic disease significant gastrointestinal bleeding ,

5. Peripheral-neuropathy > grade 2, History or presence of brain metastasis or leptomeningeal disease

6. Operable gastric or GEJ cancer

7. Herceptin (HER) 2 positive disease if the subject has not previously been treated with an anti -Herceptin (HER) 2 agent

8. 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

9. Nausea or vomiting for at least 3 consecutive days within the 14 days prior to study entry despite the administration of standard antiemetic therapy

10. Known malabsorptive disorder

11. 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)

12. Human immunodeficiency virus infection based on history of positive serology

13. 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

14. Presence of neuropathy > Grade 1

15. Prior radiation therapy to more than 25% of the bone marrow

16. Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy

17. History of severe or unexpected reaction to fluoropyrimidine therapy

18. History of hypersensitivity to fluoropyrimidine agents or any of their ingredients.

19. Known dihydropyrimidine dehydrogenase deficiency

20. Pregnancy or lactation