Gastric AdenocarcinomaPhase 2MICADONCT02007148
MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer
A Phase 2 study testing capecitabine and Docetaxel in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by International Group of Endovascular Oncology at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- capecitabine and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesItaly
- Study dates
- Nov 2013to May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
- History of severe or unexpected reaction to fluoropyrimidine therapy
- History of hypersensitivity to fluoropyrimidine agents or any of their ingredients.
- Known dihydropyrimidine dehydrogenase deficiency
- Pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
AORMN, Presidio Ospedaliero San Salvatore
Pesaro, 61122
Vincenzo Catalano, MD, +39072136 ext. 4001, catalano_v@yahoo.it
Vincenzo Catalano, MD
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore
Pesaro, 61122
Vincenzo Catalano, MD, +39072136 ext. 4001, catalano_v@yahoo.it
Vincenzo Catalano, MD
About this study
Official title: MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer Patients Previously Treated With Fluoropyrimidine and Platinum Agents MiCADO Study
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.
Read the detailed description
Despite a declining incidence in many developed countries, gastric cancer remains the second most common cause of cancer deaths, and it is responsible for about 12% of all cancer-related deaths worldwide. More than two-thirds of patients diagnosed with gastric cancer will have unresectable disease and despite the fact that surgical pathological resection can be curative for many patients, most of them develop recurrent disease. Evidence supports the use of palliative chemotherapy with the aims of improving symptoms, quality of life, and possibly prolonging survival. Combination chemotherapy regimens have been developed in the hopes of improving response rate and overall survival (OS). Unfortunately, the benefits of combination chemotherapy have been modest. In general, regimens containing fluoropyrimidine and platinum agents are widely accepted as potential standard therapies. Although a large proportion of patients with metastatic or recurrent gastric cancer may initially respond to chemotherapy, they ultimately progress. In addition, many patients have primary refractory disease. The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months.
Docetaxel is one of the most active single agents in the treatment of gastric cancer. In the first line setting, at a dose of 60-100 mg/m2 repeated every 3 weeks, response rates ranged from 17% to 20%. Docetaxel is the only taxane that has been evaluated in the context of a phase III study.
Low-dose metronomic chemotherapy represents a new strategy to treat solid tumors by exhibiting stronger anti-angiogenic activity and less side effects, especially in combination with other anti-angiogenic agents. 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. In combination with other drugs, the treatment with metronomic capecitabine has proven its efficacy with minimal toxicity in breast cancer, in metastatic renal-cell carcinoma, in advanced adrenocortical carcinoma, in hepatocellular carcinoma, in prostate cancer.
The "metronomic" strategy was also considered in pretreated elderly patients with advanced gastric cancer. Eligible patients with advanced gastric cancer were treated with capecitabine until disease progression or significant toxicity. Metronomic chemotherapy achieved a disease control rate at 8 weeks of 51.1% , and the objective response rate was 20.9% . The median time-to-progression and median overall survival were 3.6 months and 7.6 months, respectively. Grade II neutropenia and thrombocytopenia were observed in 13.3 and 2.2% of patients, respectively. Grade II/III nonhematological toxicities included diarrhea (4.4%), stomatitis (13.4%), and hand-foot syndrome (15.5%). No grade 4 toxicity, neutropenic fever or treatment-related deaths occurred.
Based on these premises and to the fact that the role of metronomic chemotherapy remains controversial, its optimal therapeutic use has not yet been defined, we designed this phase II study with tha aim to assess efficacy and tolerability of metronomic capecitabine in combination with the conventional use of docetaxel in patients with advanced gastric cancer previously treated with a fluoropyrimidine-based and platinum-based chemotherapy.
- Being tested
- capecitabine, Docetaxel
- Keywords
- gastric adenocarcinoma,, capecitabine,, second line treatment,, recurrent or metastatic disease,, overall survival,, tumor response,, quality of life
- Medical subject headings
- Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Also called xeloda
twice a day
DocetaxelDrug
Also called taxotere
cycles repeated every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: capecitabine; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response
CT scan evaluated with RECIST 1.1
Measured: 6 months
Secondary outcomes (4)
progression-free survival
progression-free survival
Measured: 6 months
overall survival
overall survival
Measured: 12 months
number of patients with Adverse Events
number of patients with Adverse Events
Measured: 6 months
time to treatment failure
time to treatment failure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Group of Endovascular Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincenzo Catalano, MD, Principal investigator, AORMN, U.O.C. Oncologia, Ospedale San Salvatore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007148
- Sponsor's protocol ID
- MICADO01
- Other IDs
- MICADO
- Acronym
- MICADO
- Status last verified
- Feb 2019
- First submitted
- 29 Nov 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11207039Graziano 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.
PubMed 11106114Catalano 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.
PubMed 19230702Catalano 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.
PubMed 22237659
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer Patients Previously Treated With Fluoropyrimidine and Platinum Agents MiCADO Study
- ClinicalTrials.gov ID
- NCT02007148
- Acronym / sponsor ID
- MICADO / MICADO01
- Keywords
- gastric adenocarcinoma,, capecitabine,, second line treatment,, recurrent or metastatic disease,, overall survival,, tumor response,, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- International Group of Endovascular OncologyUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite a declining incidence in many developed countries, gastric cancer remains the second most common cause of cancer deaths, and it is responsible for about 12% of all cancer-related deaths worldwide. More than two-thirds of patients diagnosed with gastric cancer will have unresectable disease and despite the fact that surgical pathological resection can be curative for many patients, most of them develop recurrent disease. Evidence supports the use of palliative chemotherapy with the aims of improving symptoms, quality of life, and possibly prolonging survival. Combination chemotherapy regimens have been developed in the hopes of improving response rate and overall survival (OS). Unfortunately, the benefits of combination chemotherapy have been modest. In general, regimens containing fluoropyrimidine and platinum agents are widely accepted as potential standard therapies. Although a large proportion of patients with metastatic or recurrent gastric cancer may initially respond to chemotherapy, they ultimately progress. In addition, many patients have primary refractory disease. The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months.
Docetaxel is one of the most active single agents in the treatment of gastric cancer. In the first line setting, at a dose of 60-100 mg/m2 repeated every 3 weeks, response rates ranged from 17% to 20%. Docetaxel is the only taxane that has been evaluated in the context of a phase III study.
Low-dose metronomic chemotherapy represents a new strategy to treat solid tumors by exhibiting stronger anti-angiogenic activity and less side effects, especially in combination with other anti-angiogenic agents. 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. In combination with other drugs, the treatment with metronomic capecitabine has proven its efficacy with minimal toxicity in breast cancer, in metastatic renal-cell carcinoma, in advanced adrenocortical carcinoma, in hepatocellular carcinoma, in prostate cancer.
The "metronomic" strategy was also considered in pretreated elderly patients with advanced gastric cancer. Eligible patients with advanced gastric cancer were treated with capecitabine until disease progression or significant toxicity. Metronomic chemotherapy achieved a disease control rate at 8 weeks of 51.1% , and the objective response rate was 20.9% . The median time-to-progression and median overall survival were 3.6 months and 7.6 months, respectively. Grade II neutropenia and thrombocytopenia were observed in 13.3 and 2.2% of patients, respectively. Grade II/III nonhematological toxicities included diarrhea (4.4%), stomatitis (13.4%), and hand-foot syndrome (15.5%). No grade 4 toxicity, neutropenic fever or treatment-related deaths occurred.
Based on these premises and to the fact that the role of metronomic chemotherapy remains controversial, its optimal therapeutic use has not yet been defined, we designed this phase II study with tha aim to assess efficacy and tolerability of metronomic capecitabine in combination with the conventional use of docetaxel in patients with advanced gastric cancer previously treated with a fluoropyrimidine-based and platinum-based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micado | Experimental | Drug: capecitabine, Drug: DocetaxelCAPECITABINE 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabineAlso: xelodatwice a day | Drug | micado |
| DocetaxelAlso: taxoterecycles repeated every 3 weeks | Drug | micado |
Primary outcome
tumor response
Time frame: 6 months
CT scan evaluated with RECIST 1.1
4 secondary outcomes
progression-free survival
Time frame: 6 months
overall survival
Time frame: 12 months
number of patients with Adverse Events
Time frame: 6 months
time to treatment failure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 11207039Cascinu 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.
- Background: PubMed 11106114Graziano 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.
- Background: PubMed 19230702Catalano 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.
- Background: PubMed 22237659Catalano 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.
- International group of endovascular oncology (IGEVO) websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Catalano, MD principal investigator
AORMN, U.O.C. Oncologia, Ospedale San Salvatore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine and Docetaxel in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by International Group of Endovascular Oncology at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Catalano, MD (+39072136 ext. 4001, catalano_v@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02007148, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.