Esophageal NeoplasmsPhase 1NCT00153881
Docetaxel and Carboplatin Followed by Oral Capecitabine, Docetaxel and Radiation for Esophageal Cancer
A Phase 1 study testing Capecitabine (Xeloda) in people with Esophageal Neoplasms, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The primary objective is to determine the maximum tolerated dose of oral capecitabine, in combination with fixed doses of weekly docetaxel, and concurrent thoracic radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Capecitabine (Xeloda)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Sep 2013
- Phase
- Phase 1
- 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
- Esophageal or gastroesophageal junction cancer that is locally advanced and surgically resectable (stage II or III disease).
- No prior therapy.
- Adequate organ function.
Who cannot join
- Evidence of metastasis (celiac axis lymph nodes are allowed).
- Cervical esophageal tumors.
- Peripheral or auditory neuropathy grade >= 2.
Trial locations and contacts
1 site in 1 country.
United States1 site
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
About this study
Official title: Docetaxel and Carboplatin Followed by a Dose-Ranging Study of Oral Capecitabine, Weekly Docetaxel, and Concomitant External Beam Radiotherapy for the Treatment of Patients With Stage II-III Carcinoma of the Esophagus and Gastro-Esophageal Junction
The primary objective is to determine the maximum tolerated dose of oral capecitabine, in combination with fixed doses of weekly docetaxel, and concurrent thoracic radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction.
Read the detailed description
This dose-ranging trial is designed to establish the phase II dose of capecitabine that can safely be given with docetaxel and radiation therapy for the treatment of patients with cancer of the esophagus and gastroesophageal junction. The docetaxel dose of 15 mg/m2/week, 5-fluorouracil dose of 200 mg/m2/week, and 50.4 Gy of thoracic radiation has been found to be the recommended doses from our initial phase I trial (DMS D9724). The Phase I study has been modified in an attempt to improve the pathological complete response rate by increasing the 5-fluorouracil exposure during thoracic radiation by replacing it with oral capecitabine. Capecitabine generates 5-fluorouracil selectively in tumor cells. This sequentially designed study of EUS staging, molecular analysis, neoadjuvant chemotherapy, concomitant chemotherapy and radiation, and surgical resection continues to expand our collaborative experience at Dartmouth Hitchcock in the treatment of cancer of the esophagus and gastroesophageal junction.
- Conditions
- Esophageal Neoplasms
- Being tested
- Capecitabine (Xeloda)
- Keywords
- Esophageal Cancer, Trimodality, Capecitabine, Xeloda, Gastro-esophageal Neoplasm, Carcinoma of the Esophagus
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xeloda)Drug
Also called Capecitabine, Carboplatin, Docetaxel
Neoadjuvant Chemotherapy:
Docetaxel every 3 weeks for 2 cycles Carboplatin every 3 weeks for 2 cycles with prophylactic antibiotics and antiemetics as needed.
Concomitant chemotherapy and radiation:
Docetaxel weekly for 5 doses without premedication Capecitabine orally, one dose prior to each fraction of irradiation (28 cycles).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Docetaxel/Carboplatin every 3 weeks for 2 cycles then concommitant chemotherapy and radiation Docetaxel weekly for 5 doses without premedication, then Capecitabine will be given orally, one dose prior to each fraction or irradiation (28 cycles). Receives: Drug: Capecitabine (Xeloda) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose of oral capecitabine in combination with fixed doses of weekly docetaxel and concurrent radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction.
Measured: Enrollment of first subject to accural of last subject/ and data analysis
Secondary outcomes (3)
To determine clinical and pathological response rate, rate of resectability, duration of response, and patterns of failure for patients with esophageal and gastroesophageal junction cancers.
Measured: Enrollment of first subject to accrual of last subject/ data analysis
To determine the reliability of clinical staging and antitumor response rate assessment using endoscopic ultrasound.
Measured: Enrollment of first subject to accrual of last subject/ data analysis of study.
To investigate the feasibility of assaying thymidine phosphorylase, cyclin B, MPM-2, and perturbations in cell cycle as potential markers of efficacy.
Measured: Enrollment of first subject to accrual of last/ data analysis of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2000
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- James R Rigas, MD, Principal investigator, Norris Cotton Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153881
- Sponsor's protocol ID
- D-9939
- Status last verified
- Nov 2014
- First submitted
- 7 Sep 2005
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel and Carboplatin Followed by a Dose-Ranging Study of Oral Capecitabine, Weekly Docetaxel, and Concomitant External Beam Radiotherapy for the Treatment of Patients With Stage II-III Carcinoma of the Esophagus and Gastro-Esophageal Junction
- ClinicalTrials.gov ID
- NCT00153881
- Acronym / sponsor ID
- D-9939
- Conditions
- Esophageal Neoplasms
- Keywords
- Esophageal Cancer, Trimodality, Capecitabine, Xeloda, Gastro-esophageal Neoplasm, Carcinoma of the Esophagus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Sanofi, Hoffmann-La Roche
- Study start
- Feb 2000
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Sep 2005 (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 primary objective is to determine the maximum tolerated dose of oral capecitabine, in combination with fixed doses of weekly docetaxel, and concurrent thoracic radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction.
Detailed description
This dose-ranging trial is designed to establish the phase II dose of capecitabine that can safely be given with docetaxel and radiation therapy for the treatment of patients with cancer of the esophagus and gastroesophageal junction. The docetaxel dose of 15 mg/m2/week, 5-fluorouracil dose of 200 mg/m2/week, and 50.4 Gy of thoracic radiation has been found to be the recommended doses from our initial phase I trial (DMS D9724). The Phase I study has been modified in an attempt to improve the pathological complete response rate by increasing the 5-fluorouracil exposure during thoracic radiation by replacing it with oral capecitabine. Capecitabine generates 5-fluorouracil selectively in tumor cells. This sequentially designed study of EUS staging, molecular analysis, neoadjuvant chemotherapy, concomitant chemotherapy and radiation, and surgical resection continues to expand our collaborative experience at Dartmouth Hitchcock in the treatment of cancer of the esophagus and gastroesophageal junction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Capecitabine (Xeloda)Docetaxel/Carboplatin every 3 weeks for 2 cycles then concommitant chemotherapy and radiation Docetaxel weekly for 5 doses without premedication, then Capecitabine will be given orally, one dose prior to each fraction or irradiation (28 cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Esophageal or gastroesophageal junction cancer that is locally advanced and surgically resectable (stage II or III disease).
- No prior therapy.
- Adequate organ function.
Key exclusion criteria (3 listed)
- Evidence of metastasis (celiac axis lymph nodes are allowed).
- Cervical esophageal tumors.
- Peripheral or auditory neuropathy grade >= 2.
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 |
|---|---|---|
| Capecitabine (Xeloda)Also: Capecitabine, Carboplatin, DocetaxelNeoadjuvant Chemotherapy: Docetaxel every 3 weeks for 2 cycles Carboplatin every 3 weeks for 2 cycles with prophylactic antibiotics and antiemetics as needed. Concomitant chemotherapy and radiation: Docetaxel weekly for 5 doses without premedication Capecitabine orally, one dose prior to each fraction of irradiation (28 cycles). | Drug | 1 |
Primary outcome
To determine the maximum tolerated dose of oral capecitabine in combination with fixed doses of weekly docetaxel and concurrent radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction.
Time frame: Enrollment of first subject to accural of last subject/ and data analysis
3 secondary outcomes
To determine clinical and pathological response rate, rate of resectability, duration of response, and patterns of failure for patients with esophageal and gastroesophageal junction cancers.
Time frame: Enrollment of first subject to accrual of last subject/ data analysis
To determine the reliability of clinical staging and antitumor response rate assessment using endoscopic ultrasound.
Time frame: Enrollment of first subject to accrual of last subject/ data analysis of study.
To investigate the feasibility of assaying thymidine phosphorylase, cyclin B, MPM-2, and perturbations in cell cycle as potential markers of efficacy.
Time frame: Enrollment of first subject to accrual of last/ data analysis of study.
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 13 Nov 2014.
Related trials for Esophageal Neoplasms
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
James R Rigas, MD principal investigator
Norris Cotton Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capecitabine (Xeloda) in people with Esophageal Neoplasms, run by Dartmouth-Hitchcock Medical Center 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 3 inclusion and 3 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 13 Nov 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine the maximum tolerated dose of oral capecitabine in combination with fixed doses of weekly docetaxel and concurrent radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction. (time frame: Enrollment of first subject to accural of last subject/ and data analysis). 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 13 Nov 2014.