Metastatic Esophageal CancerPhase 2NCT01715233
Phase II Study Using CHFR Methylation Status in Patients With Metastatic Esophageal, Gastroesophageal, Gastric Cancer.
A Phase 2 study testing Docetaxel, Leucovorin and Fluorouracil in people with Metastatic Esophageal Cancer and Gastroesophageal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Esophageal Cancer, Gastroesophageal Cancer, Gastric Cancer
- What is being tested?
- Docetaxel, Leucovorin and Fluorouracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have metastatic disease of the esophagus, gastroesophageal junction or stomach. Patients with locally recurrent disease who are not deemed eligible for radiation are also permitted.
- Histological, cytologic or radiographic documentation of metastatic adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction or stomach. Radiologic, endoscopic, histologic or cytologic evidence of locally recurrent disease is also permitted.
- Patients must be untreated with chemotherapy for metastatic or locally recurrent disease. Prior radiation therapy is permitted.
- Patients must have measurable disease as per RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Age >18 years and ≤ 80 years.
- ECOG performance status <2 (Karnofsky >60%, see Appendix A).
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- Life expectancy of greater than 3 months.
- Patients must have normal organ and marrow function.
- Patients must not have any of the following conditions:
- Recent major surgery, hormonal therapy (other than replacement) or chemotherapy, within 4 weeks prior to entering the study or those who have not recovered from the adverse events of treatment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy on this trial.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who are receiving any investigational agents.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy used in the study.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort; these drugs induce CYP3A and may decrease levels of taxanes. 5-FU is a strong CYP2C9 inducer, and concomitant use with carvedilol, celecoxib, fosphenytoin, fluoxetine, phenytoin, warfarin and other CYP2C9 substrates should be used with caution.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because chemotherapy has the potential for teratogenic or abortifacient effects.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with chemotherapeutic agents. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study Investigating CHFR Methylation Status As A Biomarker For Taxane Sensitivity Using Modified Docetaxel, Cisplatin and 5 Fluorouracil In Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.
To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR.
Read the detailed description
To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR. The overall response rates in the un-methylated and methylated patient groups will be reported with a exact 95% binomial confidence interval. A chi-square test will be used for comparison.
- Being tested
- Docetaxel, Leucovorin, Fluorouracil, Cisplatin
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Modified DCF
Modified Docetaxel 40mg/m2 on Day 1
LeucovorinDrug
Leucovorin 400mg/m2 on Day 1
FluorouracilDrug
Also called FU
Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2
CisplatinDrug
Also called Carboplatin
Cisplatin (or Carboplatin) 40mg/m2 on Day 3
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Esophageal, Gastroesophageal & Gastric Cancer | Experimental | Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. Receives: Drug: Docetaxel; Drug: Leucovorin; Drug: Fluorouracil; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Number of participants treated with mDCF with progressive disease (PD), stable disease (SD), partial response (PR), non-complete response and non-progressive disease (non-CR/non-PD), and partial response with progressive disease clinically (PR/PD) as defined by RECIST criteria. Response is compared based on CHFR-methylation status.
Measured: 4 months
Secondary outcomes (2)
CHFR Methylation Status
Number of participants with advanced esophagogastric cancer that are CHFR-methylated or unmethylated at baseline.
Measured: Baseline
Overall Survival
Number of participants alive at 2 years.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronan J Kelly, MD, MBA, Principal investigator, SKCCC at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715233
- Sponsor's protocol ID
- J1248
- Other IDs
- NA_00073720
- Status last verified
- Mar 2019
- First submitted
- 24 Oct 2012
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Investigating CHFR Methylation Status As A Biomarker For Taxane Sensitivity Using Modified Docetaxel, Cisplatin and 5 Fluorouracil In Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.
- ClinicalTrials.gov ID
- NCT01715233
- Acronym / sponsor ID
- J1248
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Posted 15 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR.
Detailed description
To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR. The overall response rates in the un-methylated and methylated patient groups will be reported with a exact 95% binomial confidence interval. A chi-square test will be used for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Esophageal, Gastroesophageal & Gastric Cancer | Experimental | Drug: Docetaxel, Drug: Leucovorin, Drug: Fluorouracil, Drug: CisplatinParticipants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have metastatic disease of the esophagus, gastroesophageal junction or stomach. Patients with locally recurrent disease who are not deemed eligible for radiation are also permitted.
- Histological, cytologic or radiographic documentation of metastatic adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction or stomach. Radiologic, endoscopic, histologic or cytologic evidence of locally recurrent disease is also permitted.
- Patients must be untreated with chemotherapy for metastatic or locally recurrent disease. Prior radiation therapy is permitted.
- Patients must have measurable disease as per RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Age >18 years and ≤ 80 years.
Key exclusion criteria (8 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who are receiving any investigational agents.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy used in the study.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort; these drugs induce CYP3A and may decrease levels of taxanes. 5-FU is a strong CYP2C9 inducer, and concomitant use with carvedilol, celecoxib, fosphenytoin, fluoxetine, phenytoin, warfarin and other CYP2C9 substrates should be used with caution.
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 |
|---|---|---|
| DocetaxelAlso: Modified DCFModified Docetaxel 40mg/m2 on Day 1 | Drug | Metastatic Esophageal, Gastroesophageal & Gastric Cancer |
| LeucovorinLeucovorin 400mg/m2 on Day 1 | Drug | Metastatic Esophageal, Gastroesophageal & Gastric Cancer |
| FluorouracilAlso: FUFluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 | Drug | Metastatic Esophageal, Gastroesophageal & Gastric Cancer |
| CisplatinAlso: CarboplatinCisplatin (or Carboplatin) 40mg/m2 on Day 3 | Drug | Metastatic Esophageal, Gastroesophageal & Gastric Cancer |
Primary outcome
Response
Time frame: 4 months
Number of participants treated with mDCF with progressive disease (PD), stable disease (SD), partial response (PR), non-complete response and non-progressive disease (non-CR/non-PD), and partial response with progressive disease clinically (PR/PD) as defined by RECIST criteria. Response is compared based on CHFR-methylation status.
2 secondary outcomes
CHFR Methylation Status
Time frame: Baseline
Overall Survival
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ronan J Kelly, MD, MBA principal investigator
SKCCC at Johns Hopkins
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, Leucovorin and Fluorouracil in people with Metastatic Esophageal Cancer and Gastroesophageal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
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 12 inclusion and 8 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 15 Mar 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2019.