Stomach CancerPhase 2NCT04770623
Docetaxel and Irinotecan in Gastric Cancer
A Phase 2 study testing Docetaxel and Irinotecan in people with Stomach Cancer and Gastric Cancer, run by Menoufia University at 1 site in Egypt.
Trial summary
To assess the role of docetaxel and irinotecan combination in second line gastric cancer. The primary end point is response rate. Secondary end points are toxicity, PFS and OS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stomach Cancer, Gastric Cancer, Chemotherapy Effect
- What is being tested?
- Docetaxel and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2021to 9 Jan 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological evidence of adenocarcinoma of the stomach
- Metastatic disease or locally advanced non-resectable disease
- Patients who received only one line of treatment
- Performance status 0,1,2 as per ECOG scoring system
Who cannot join
- Patients who received docetaxel or irinotecan before recruitment to this study
- Multiple comorbid conditions
- Liver or kidney impairment
- Severe cachexia (sarcopenia)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Menoufia University, Faculty of medicine
Shibīn al Kawm, Menoufia, 32511
About this study
Official title: Docetaxel and Irinotecan Combination as a Second Line Treatment of Metastatic Gastric Cancer; a Phase II Study
To assess the role of docetaxel and irinotecan combination in second line gastric cancer. The primary end point is response rate. Secondary end points are toxicity, PFS and OS.
Read the detailed description
Gastric cancer is a major killer in oncology. The expected overall survival of metastatic patients is less than 2 years. Moreover, most of the patients develop cachexia and worsening of performance over time. As a result, many patients are not fit for second line treatment when eligible. There is currently no approved consensus for third line treatment regimen and in most of the patients it is usually best supportive care.
Irinotecan and docetaxel were tested as single agents or in combination with other drugs (e.g. FOLFIRI) in second line setting. However, the combination of these two drugs together was not tested before. Both agents are active in second line setting which is considered the last chance of the patient in view of lack of evidence in third line setting.
- Conditions
- Stomach Cancer, Gastric Cancer, Chemotherapy Effect
- Being tested
- Docetaxel, Irinotecan
- Keywords
- gastric, stomach, docetaxel, irinotecan, chemotherapy, second line
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival
IrinotecanDrug
patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Second line treatment will be as follows
* Docetaxel at 30 mg/m2 over 500 cc normal saline over 1 hour infusion
* Irinotecan at 185 mg/m2 with a maximum of 300 mg given over 500 cc normal saline over 2 hours infusion
* The whole regimen is to be cycled every 2 weeks for a maximum of 6 months with interim and end of treatment evaluation Receives: Drug: Docetaxel; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
described according to RECIST criteria
Measured: 6 months from chemotherapy
Secondary outcomes (3)
Quality of life (QoL)
A questionnaire with the QLQ-C30 form will be conducted at enrollment, after 3 months and after end of treatment.
A score between 1 to 4 will be used in the questionnaire where higher score means worse quality of life.
Measured: three months and six months from chemotherapy
Progression free survival (PFS)
The time interval between starting the test protocol and the next disease progression or death whichever earlier
Measured: One year from start of enrollment
Overall survival (OS)
The time interval between diagnosis and death
Measured: One year from start of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start5 Mar 2021
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- Model description
- Patients from multiple oncology centers across Egypt are recruited for this study. Second line treatment of advanced gastric cancer will be tested with irinotecan and docetaxel combination
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sohaib, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770623
- Sponsor's protocol ID
- 360
- Status last verified
- Jan 2024
- First submitted
- 19 Feb 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators of this study agreed to share IPD for free with any other investigators with the following conditions: * Sharing the data will be after publishing the primary results * Other studies using our data should submit our names as sub-investigators when publishing their results.
Publications
Catalano V, Graziano F, Santini D, D'Emidio S, Baldelli AM, Rossi D, Vincenzi B, Giordani P, Alessandroni P, Testa E, Tonini G, Catalano G. Second-line chemotherapy for patients with advanced gastric cancer: who may benefit? Br J Cancer. 2008 Nov 4;99(9):1402-7. doi: 10.1038/sj.bjc.6604732.
PubMed 18971936Shitara K, Muro K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Yamaguchi K, Segawa Y, Omuro Y, Tamura T, Doi T, Yukisawa S, Yasui H, Nagashima F, Gotoh M, Esaki T, Emig M, Chandrawansa K, Liepa AM, Wilke H, Ichimiya Y, Ohtsu A. Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28.
PubMed 26510663Tetzlaff ED, Cheng JD, Ajani JA. Review of docetaxel in the treatment of gastric cancer. Ther Clin Risk Manag. 2008 Oct;4(5):999-1007. doi: 10.2147/tcrm.s3226.
PubMed 19209281Farhat FS. A general review of the role of irinotecan (CPT11) in the treatment of gastric cancer. Med Oncol. 2007;24(2):137-46. doi: 10.1007/BF02698032.
PubMed 17848736Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.
PubMed 21742485
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel and Irinotecan Combination as a Second Line Treatment of Metastatic Gastric Cancer; a Phase II Study
- ClinicalTrials.gov ID
- NCT04770623
- Acronym / sponsor ID
- 360
- Conditions
- Stomach Cancer, Gastric Cancer, Chemotherapy Effect
- Keywords
- gastric, stomach, docetaxel, irinotecan, chemotherapy, second line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 25 Feb 2021 (actual)
- 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.
To assess the role of docetaxel and irinotecan combination in second line gastric cancer. The primary end point is response rate. Secondary end points are toxicity, PFS and OS.
Detailed description
Gastric cancer is a major killer in oncology. The expected overall survival of metastatic patients is less than 2 years. Moreover, most of the patients develop cachexia and worsening of performance over time. As a result, many patients are not fit for second line treatment when eligible. There is currently no approved consensus for third line treatment regimen and in most of the patients it is usually best supportive care.
Irinotecan and docetaxel were tested as single agents or in combination with other drugs (e.g. FOLFIRI) in second line setting. However, the combination of these two drugs together was not tested before. Both agents are active in second line setting which is considered the last chance of the patient in view of lack of evidence in third line setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients from multiple oncology centers across Egypt are recruited for this study. Second line treatment of advanced gastric cancer will be tested with irinotecan and docetaxel combination
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Docetaxel, Drug: IrinotecanSecond line treatment will be as follows * Docetaxel at 30 mg/m2 over 500 cc normal saline over 1 hour infusion * Irinotecan at 185 mg/m2 with a maximum of 300 mg given over 500 cc normal saline over 2 hours infusion * The whole regimen is to be cycled every 2 weeks for a maximum of 6 months with interim and end of treatment evaluation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histopathological evidence of adenocarcinoma of the stomach
- Metastatic disease or locally advanced non-resectable disease
- Patients who received only one line of treatment
- Performance status 0,1,2 as per ECOG scoring system
Key exclusion criteria (4 listed)
- Patients who received docetaxel or irinotecan before recruitment to this study
- Multiple comorbid conditions
- Liver or kidney impairment
- Severe cachexia (sarcopenia)
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 |
|---|---|---|
| Docetaxelpatients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival | Drug | Chemotherapy |
| Irinotecanpatients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival | Drug | Chemotherapy |
Primary outcome
Overall response rate (ORR)
Time frame: 6 months from chemotherapy
described according to RECIST criteria
3 secondary outcomes
Quality of life (QoL)
Time frame: three months and six months from chemotherapy
Progression free survival (PFS)
Time frame: One year from start of enrollment
Overall survival (OS)
Time frame: One year from start of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 18971936Catalano V, Graziano F, Santini D, D'Emidio S, Baldelli AM, Rossi D, Vincenzi B, Giordani P, Alessandroni P, Testa E, Tonini G, Catalano G. Second-line chemotherapy for patients with advanced gastric cancer: who may benefit? Br J Cancer. 2008 Nov 4;99(9):1402-7. doi: 10.1038/sj.bjc.6604732.
- Background: PubMed 26510663Shitara K, Muro K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Yamaguchi K, Segawa Y, Omuro Y, Tamura T, Doi T, Yukisawa S, Yasui H, Nagashima F, Gotoh M, Esaki T, Emig M, Chandrawansa K, Liepa AM, Wilke H, Ichimiya Y, Ohtsu A. Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28.
- Background: PubMed 19209281Tetzlaff ED, Cheng JD, Ajani JA. Review of docetaxel in the treatment of gastric cancer. Ther Clin Risk Manag. 2008 Oct;4(5):999-1007. doi: 10.2147/tcrm.s3226.
- Background: PubMed 17848736Farhat FS. A general review of the role of irinotecan (CPT11) in the treatment of gastric cancer. Med Oncol. 2007;24(2):137-46. doi: 10.1007/BF02698032.
- Background: PubMed 21742485Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.
- Individual participant dataSharing planned: Yes. Investigators of this study agreed to share IPD for free with any other investigators with the following conditions: * Sharing the data will be after publishing the primary results * Other studies using our data should submit our names as sub-investigators when publishing their results.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Irinotecan in people with Stomach Cancer and Gastric Cancer, run by Menoufia University at 1 site in Egypt.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 6 months from chemotherapy). 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 NCT04770623, which also lists 5 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 30 Jan 2024.