Esophageal CancerPhase 2NCT01444547
A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin
A Phase 2 study testing paclitaxel and cisplatin in people with Esophageal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- paclitaxel and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Dec 2015
- 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
- Histologically proven diagnosis of the squamous cell carcinoma or adenocarcinoma of esophagus
- locally advanced, recurrent or metastatic disease
- Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale
- Previous adjuvant or pre-operative chemotherapy without containing paclitaxel or platinum at least 12 months before enrollment
- Adequate organ function including the following:
- Bone marrow: absolute neutrophil count (ANC) >or equal to 1.5 109/L, platelets >or equal to 100 109/L, hemoglobin > or equal to 10 g/dL.
- Hepatic: bilirubin < or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin > or equal to3g/dL.
- Renal: Calculated creatinine clearance major or equal to 60 ml/min (using the standard Cockcroft-Gault formula).
Who cannot join
- No Prior palliative chemotherapy for advanced disease
- Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment
- Known or suspected brain metastasis
- Second primary malignancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Yi Zhou, M.D, 8610-87788800, mondaycm@yahoo.com.cn
Xiao Lv, M.D, 8610-87788800, xiaoxiao81473@126.com
About this study
Official title: A Phase Ⅱ Study on Low-expression and High-expression of ERCC1 in Recurrent or Metastastic Esophageal Cancer Patients Treated With Biweekly Paclitaxel and Cisplatin
The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer
Read the detailed description
Open label single arm phase II study of cisplatin and paclitaxel in patients with recurrent or metastatic esophageal cancer. 92 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: paclitaxel 150 mg/m2 will be administered as an intravenous infusion over 3 hour on Days 1, followed by cisplatin 50 mg/m2 on Days 2. This study will also include the investigation of ERCC1 expression in order to assess determinants of efficacy of the treatment with cisplatin and paclitaxel in the study population.
- Conditions
- Esophageal Cancer
- Being tested
- paclitaxel and cisplatin
- Keywords
- esophageal cancer, paclitaxel, cisplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel and cisplatinDrug
Also called Paclitaxel,Beijing Union Pharmaceutical Factory
Paclitaxel 150 mg/m2 will be administered as an intravenous (IV) infusion over 3 hour on Days 1; Cisplatin 50 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day.
14 days as a cycle, up to 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| single-arm Paclitaxel-Cisplatin | Experimental | Not described Receives: Drug: paclitaxel and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
The primary objective of this study is to determine the response rate of paclitaxel plus cisplatin as first-line therapy in patients with locally advanced, recurrent or metastatic esophageal carcinoma
Measured: 5 year
Secondary outcomes (1)
Time to event efficay
The following time to event efficacy measures:
- Duration of overall response for responding patients
- Time to documented progressive disease
- Overall survival
- The quantitative and qualitative toxicity of paclitaxel plus cisplatin.
- Determinant of efficacy of the treatment with paclitaxel and cisplatin in the patient population by means of the analysis of ERCC1
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startJan 2007
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Jing Huang, Chinese Academy of Medical Sciences
- Investigators
- Jing Huang, M.D.,Ph.D, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444547
- Sponsor's protocol ID
- CH-GI-021
- Other IDs
- Z111107058811023
- Status last verified
- May 2014
- First submitted
- 28 Sep 2011
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee S, Park YH, Kim KH, Cho EY, Ahn YC, Kim K, Shim YM, Ahn JS, Park K, Im YH. Thymidine synthase, thymidine phosphorylase, and excision repair cross-complementation group 1 expression as predictive markers of capecitabine plus cisplatin chemotherapy as first-line treatment for patients with advanced oesophageal squamous cell carcinoma. Br J Cancer. 2010 Sep 7;103(6):845-51. doi: 10.1038/sj.bjc.6605831. Epub 2010 Aug 10.
PubMed 20700125Olaussen KA, Fouret P, Kroemer G. ERCC1-specific immunostaining in non-small-cell lung cancer. N Engl J Med. 2007 Oct 11;357(15):1559-61. doi: 10.1056/NEJMc072007. No abstract available.
PubMed 17928611
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Study on Low-expression and High-expression of ERCC1 in Recurrent or Metastastic Esophageal Cancer Patients Treated With Biweekly Paclitaxel and Cisplatin
- ClinicalTrials.gov ID
- NCT01444547
- Acronym / sponsor ID
- CH-GI-021
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, paclitaxel, cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Jan 2007
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Sep 2011 (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.
The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer
Detailed description
Open label single arm phase II study of cisplatin and paclitaxel in patients with recurrent or metastatic esophageal cancer. 92 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: paclitaxel 150 mg/m2 will be administered as an intravenous infusion over 3 hour on Days 1, followed by cisplatin 50 mg/m2 on Days 2. This study will also include the investigation of ERCC1 expression in order to assess determinants of efficacy of the treatment with cisplatin and paclitaxel in the study population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm Paclitaxel-Cisplatin | Experimental | Drug: paclitaxel and cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven diagnosis of the squamous cell carcinoma or adenocarcinoma of esophagus
- locally advanced, recurrent or metastatic disease
- Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale
- Previous adjuvant or pre-operative chemotherapy without containing paclitaxel or platinum at least 12 months before enrollment
- Adequate organ function including the following:
Key exclusion criteria (4 listed)
- No Prior palliative chemotherapy for advanced disease
- Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment
- Known or suspected brain metastasis
- Second primary malignancy
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 |
|---|---|---|
| paclitaxel and cisplatinAlso: Paclitaxel,Beijing Union Pharmaceutical FactoryPaclitaxel 150 mg/m2 will be administered as an intravenous (IV) infusion over 3 hour on Days 1; Cisplatin 50 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day. 14 days as a cycle, up to 8 cycles. | Drug | single-arm Paclitaxel-Cisplatin |
Primary outcome
Overall response rate (ORR)
Time frame: 5 year
The primary objective of this study is to determine the response rate of paclitaxel plus cisplatin as first-line therapy in patients with locally advanced, recurrent or metastatic esophageal carcinoma
1 secondary outcome
Time to event efficay
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- Results publication: PubMed 20700125Lee S, Park YH, Kim KH, Cho EY, Ahn YC, Kim K, Shim YM, Ahn JS, Park K, Im YH. Thymidine synthase, thymidine phosphorylase, and excision repair cross-complementation group 1 expression as predictive markers of capecitabine plus cisplatin chemotherapy as first-line treatment for patients with advanced oesophageal squamous cell carcinoma. Br J Cancer. 2010 Sep 7;103(6):845-51. doi: 10.1038/sj.bjc.6605831. Epub 2010 Aug 10.
- Results publication: PubMed 17928611Olaussen KA, Fouret P, Kroemer G. ERCC1-specific immunostaining in non-small-cell lung cancer. N Engl J Med. 2007 Oct 11;357(15):1559-61. doi: 10.1056/NEJMc072007. No abstract available.
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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.
Jing Huang, M.D.,Ph.D principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 paclitaxel and cisplatin in people with Esophageal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
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 8 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: status not confirmed, as of the sponsor's last update on 6 May 2014. 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 China. 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 Yi Zhou, M.D (8610-87788800, mondaycm@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 5 year). 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 NCT01444547, which also lists 2 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 6 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.