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

NCT02007148 | Unknown Phase 2

• 2 other identifiers: MICADO01MICADO
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Keywords

gastric adenocarcinoma,; capecitabine,; second line treatment,; recurrent or metastatic disease,; overall survival,; tumor response,; quality of life

Outcome Measures

Primary Outcomes (1)

• tumor response

  CT scan evaluated with RECIST 1.1

  6 months

Secondary Outcomes (4)

• progression-free survival

  6 months

• overall survival

  12 months

• number of patients with Adverse Events

  6 months

• time to treatment failure

  6 months

Study Arms (1)

micado

EXPERIMENTAL

CAPECITABINE 500 mg twice a day, orally, continuously DOCETAXEL 60 mg/sqm i.v. over 1 hr on day 1 cycles repeated every 3 weeks Duration of treatment: Chemotherapy should be continued until: progressive disease; unacceptable toxicities; patients' refusal; or upon investigator's judgement is in the best interest for the patient.

Drug: capecitabine; Drug: Docetaxel

Interventions

capecitabine DRUG

twice a day

Also known as: xeloda

micado

Docetaxel DRUG

cycles repeated every 3 weeks

Also known as: taxotere

micado

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (GEJ)
• Measurable disease based on computed tomography
• Eastern Cooperative Oncology Group performance status 0 or 1
• Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum agent
• 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)
• Adequate bone marrow, hepatic, and renal function,
• At least 4 weeks and recovery from effects of prior major surgery or radiation therapy
• 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.)
• 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
• Agreement to use an effective form of contraception
• Signed written informed consent.
• Ability to comprehend and to comply with the requirements of the study.

You may not qualify if:

• Squamous cell gastric carcinoma
• Bone-only metastatic disease
• History or presence of brain metastasis or leptomeningeal disease
• Operable gastric or GEJ cancer
• Herceptin 2 (HER2) -positive disease if the subject has not previously been treated with an anti-HER2 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 treatment including docetaxel
• Prior radiation therapy to more than 25% of the bone marrow
• Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy

Sponsors & Collaborators

• International Group of Endovascular Oncology: lead

Study Sites (2)

AORMN, Presidio Ospedaliero San Salvatore

Pesaro, 61122, Italy

RECRUITING

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore

Pesaro, 61122, Italy

RECRUITING

Related Publications (4)

• Cascinu S, Graziano F, Barni S, Labianca R, Comella G, Casaretti R, Frontini L, Catalano V, Baldelli AM, Catalano G. A phase II study of sequential chemotherapy with docetaxel after the weekly PELF regimen in advanced gastric cancer. A report from the Italian group for the study of digestive tract cancer. Br J Cancer. 2001 Feb;84(4):470-4. doi: 10.1054/bjoc.2000.1631.

  PMID: 11207039 BACKGROUND

• Graziano F, Catalano V, Baldelli AM, Giordani P, Testa E, Lai V, Catalano G, Battelli N, Cascinu S. A phase II study of weekly docetaxel as salvage chemotherapy for advanced gastric cancer. Ann Oncol. 2000 Oct;11(10):1263-6. doi: 10.1023/a:1008373814453.

  PMID: 11106114 BACKGROUND

• 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: 19230702 BACKGROUND

• 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: 22237659 BACKGROUND

Related Links

• International group of endovascular oncology (IGEVO) website

MeSH Terms

Conditions

Recurrence; Neoplasm Metastasis

Interventions

Capecitabine; Docetaxel

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Vincenzo Catalano, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Catalano, MD

CONTACT

+39072136; catalano_v@yahoo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 10, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2021
• Study Completion: May 1, 2022
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

IT (2)