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Esophagus CancerPhase 1/2NCT00193128

Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer

A Phase 1/2 study testing Oxaliplatin, Docetaxel and Capecitabine in people with Esophagus Cancer, run by SCRI Development Innovations, LLC at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma 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
Esophagus Cancer
What is being tested?
Oxaliplatin, Docetaxel and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
7 sitesUnited States
Study dates
Apr 2004to Jan 2009
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be included in this study, you must meet the following criteria:
  • Adenocarcinoma or squamous cell carcinoma of the esophagus or G/E junction.
  • Must be surgical candidates
  • No previous treatment for esophageal cancer
  • Must have measurable or evaluable disease
  • Able to perform activities of daily living with minimal to no assistance
  • Adequate bone marrow, liver and kidney function
  • Provide written informed consent

Who cannot join

  • You cannot participate in this study if any of the following apply to you:
  • Tumor location in the proximal esophagus
  • Metastatic disease or locally advanced cancer
  • Moderate to severe peripheral neuropathy
  • Serious pre-existing medical illnesses
  • Significant heart disease
Show all 10Show fewer
  • Treated for an invasive cancer within the previous 5 years
  • Women who are pregnant or breast-feeding
  • Age < 18 years
  • Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Atlanta Cancer Care

    Atlanta, Georgia, 30342

  • Tower Oncology

    Beverly Hills, California, 90211

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32256

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Wellstar Cancer Research

    Marietta, Georgia, 30060

  • Tennessee Oncology

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: A Phase I/II Trial of Preoperative Oxaliplatin, Docetaxel, and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction

In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.

Read the detailed description

Upon determination of eligibility, patients will be receive:

Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy

If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy

Being tested
Oxaliplatin, Docetaxel, Capecitabine, Radiation therapy
Keywords
Esophagus Cancer
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    Also called Eloxatin

    40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts

  • DocetaxelDrug

    Also called Taxotere

    20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts

  • CapecitabineDrug

    Also called Xeloda

    In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.

  • Radiation therapyRadiation

    Also called RT

    In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).

Study groups in NCT00193128
Study groupRoleWhat they receive
Cohort 1ExperimentalOxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.
Receives: Drug: Oxaliplatin; Drug: Docetaxel; Radiation: Radiation therapy
Cohort 2ExperimentalOxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.
Receives: Drug: Oxaliplatin; Drug: Docetaxel; Drug: Capecitabine; Radiation: Radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery

    The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response

    Measured: 18 months

Secondary outcomes (2)

  1. Disease-Free Survival (DFS)

    Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.

    Measured: 18 months

  2. Overall Survival (OS)

    Length of time, in months, that patients were alive from their first date of protocol treatment until death.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startApr 2004
  3. Primary completionFeb 2008
  4. Study completionJan 2009

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00193128
Sponsor's protocol ID
SCRI GI 57
Status last verified
Oct 2021
First submitted
12 Sep 2005
Last updated
24 Nov 2021
Data monitoring committee
No

Publications

  • Spigel DR, Greco FA, Meluch AA, Lane CM, Farley C, Gray JR, Clark BL, Burris HA 3rd, Hainsworth JD. Phase I/II trial of preoperative oxaliplatin, docetaxel, and capecitabine with concurrent radiation therapy in localized carcinoma of the esophagus or gastroesophageal junction. J Clin Oncol. 2010 May 1;28(13):2213-9. doi: 10.1200/JCO.2009.24.8773. Epub 2010 Mar 29.

    PubMed 20351330

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oxaliplatin, Docetaxel and Capecitabine in people with Esophagus Cancer, run by SCRI Development Innovations, LLC at 7 sites 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 8 inclusion and 10 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 combined 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.

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 13 May 2013). 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?

Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery (time frame: 18 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 NCT00193128, which also lists 1 linked publication.

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 24 Nov 2021.

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