MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer

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

Summary

Second-line chemotherapy represents an option in gastric cancer, especially for patients with adequate performance status. Two randomized phase III trials comparing 2nd-line docetaxel with best-supportive care have reported a benefit in favor of chemotherapy. Capecitabine is a fluoropyrimidine carbamate, which has a broader spectrum of antitumor activity than other fluoropyrimidines. In gastric cancer xenografts. metronomic capecitabine inhibited angiogenesis, growth of gastric cancer and improved survival with less toxicity. Given its potential low toxicity, the combination of docetaxel and metronomic capecitabine needs to be evaluated to assess efficacy and tolerability in patients with advanced gastric cancer previously treated with a fluoropyrimidine-based and platinum-based chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Group of Endovascular Oncology
• Treatments: Capecitabine; Docetaxel

Criteria

Inclusion Criteria:

1. At least 18 years of age

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

3. Measurable disease based on computed tomography

4. Eastern Cooperative Oncology Group performance status 0 or 1

5. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum agent

6. Disease progression after the start of the prior regimen based on computed tomography (or magnetic resonance imaging in the event of allergy to contrast medium)

7. Adequate bone marrow, hepatic, and renal function,

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

9. If previously administered as treatment for gastric cancer, prior to study entry a washout period equivalent to at least 5 half-lives for antibodies and of at least 28 days for chemotherapy (Concurrent use of bisphosphonates is permitted.)

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

11. A negative serum pregnancy test within 7 days prior to accrual in women of childbearing potential

12. Agreement to use an effective form of contraception

13. Signed written informed consent.

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

Exclusion Criteria:

1. Squamous cell gastric carcinoma

2. Bone-only metastatic disease

3. History or presence of brain metastasis or leptomeningeal disease

4. Operable gastric or GEJ cancer

5. Herceptin 2 (HER2) -positive disease if the subject has not previously been treated with an anti-HER2 agent

6. 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

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

8. Known malabsorptive disorder

9. 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)

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

11. 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

12. Presence of neuropathy > Grade 1

13. Prior treatment including docetaxel

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

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

16. History of severe or unexpected reaction to fluoropyrimidine therapy

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

18. Known dihydropyrimidine dehydrogenase deficiency

19. Pregnancy or lactation