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Adenocarcinoma of the EsophagusPhase 2NCT01129206

Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy

A Phase 2 study testing pralatrexate, docetaxel and fludeoxyglucose F 18 in people with Adenocarcinoma of the Esophagus and Adenocarcinomas of the Gastroesophageal Junction, run by Ohio State University Comprehensive Cancer Center at 1 site 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

RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
pralatrexate, docetaxel and fludeoxyglucose F 18
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Jul 2010to Sep 2012
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed unresectable advanced or metastatic carcinoma of the esophagus or gastroesophageal junction
  • Established histological confirmation of squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
  • Stage IV disease
  • Must have received platinum-based therapy; this includes definitive, adjuvant and metastatic treatments
  • No more than 3 chemotherapeutic treatment regimens permitted; this includes concurrent chemoradiation
  • Radiation therapy allowed if > 4 weeks have elapsed
Show all 19Show fewer
  • Must be off therapy for 4 weeks prior to enrollment
  • Measurable disease as defined by RECIST v 1.1 criteria
  • ECOG (Eastern Cooperative Oncology Group)PS(Performance status)of 0 to 2
  • Predicted life expectancy of at least 12 weeks
  • Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial and for three months after completion of treatment
  • Marrow: ANC(absolute neutrophil count)> 1,000/mm^3
  • Marrow: Hemoglobin > 9.0 g/dl
  • Marrow: Platelet Count > 100,000/mm^3
  • Renal: Serum creatinine =< 1.5 g/dL
  • Hepatic: Serum bilirubin < 1.5 x ULN(upper limit of normal) and AST (aspartate aminotransferase) and ALT (Alanine aminotransferase)=< 2.5 x ULN
  • Prior minor surgeries (such as laparoscopies) must have occurred at least 14 days prior to study enrollment; prior minor procedures such as biopsies and mediport placement must have occurred at least 48 hours prior to study enrollment
  • All patients must have signed an informed consent indicating that they are aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
  • History of allergic reactions attributed to compounds of similar chemical composition to agents used in the study

Who cannot join

  • Pregnant or lactating women
  • Patients with any severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry
  • Any malignant condition for which one has received treatment in the last two years excluding squamous or basal cell carcinomas
  • Patients with untreated brain metastases
  • Patients must not have grade 2 or higher baseline peripheral neuropathy, according to CTCAE v 4.0
  • Patients must have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy, chemotherapy, or surgical procedures; all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE v 4.0) Grade =< 1 prior to study enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy.

RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pralatrexate together with docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving pralatrexate together with docetaxel works in treating patients with stage IV esophageal or gastroesophageal cancer who have failed platinum-based therapy.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate overall response rate CR \& PR(Complete Response + Partial Response)as assessed by RECIST (Response Evaluation Criteria in Solid Tumors v 1.1) of the combination of pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinomas.

SECONDARY OBJECTIVES:

  1. Evaluation of progression free survival and overall survival. II. Correlation of FDG(fludeoxyglucose)PET(positron emission tomography)response defined as a 35% reduction in SUV(standard uptake value)during the early course of chemotherapy to progression free and overall survival in addition to radiographic response as measured by RECIST v 1.1 criteria on CT imaging.

OUTLINE:

Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Being tested
pralatrexate, docetaxel, fludeoxyglucose F 18, positron emission tomography
Keywords
Gastroesophageal Cancer, Gastroesophageal Carcinoma, Adenocarcinoma
Medical subject headings
Adenocarcinoma Of Esophagus, Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Adenocarcinoma

What participants receive

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

  • pralatrexateDrug

    Also called FOLOTYN, PDX

    IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.

  • docetaxelDrug

    Also called RP 56976, Taxotere, TXT

    Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.

  • fludeoxyglucose F 18Radiation

    Also called 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F 18

    Correlative studies

  • positron emission tomographyProcedure or surgery

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Correlative studies

Study groups in NCT01129206
Study groupRoleWhat they receive
Arm IExperimentalPatients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: pralatrexate; Drug: docetaxel; Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography

What is being measured

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

  1. Overall Response

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: Approximately three years

Secondary outcomes (3)

  1. Progression-free Survival (PFS)

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: Approximately three years

  2. Overall Survival (OS)

    OS was determined from the date of start of therapy to death frm any cause.

    Measured: Approximately five years

  3. Correlation of FDG PET Response With Response Rate

    Radiological assessment of tumor response was performed by computed tomography (CT) and positron emission tomography (PET) every four cycles of therapy and responses were measured according to RECIST and PERCIST criteria.

    Measured: Approximately three years

Timeline

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

  1. First posted24 May 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionSep 2012

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01129206
Sponsor's protocol ID
OSU-10018
Other IDs
NCI-2010-01225
Status last verified
Apr 2016
First submitted
21 May 2010
Last updated
1 Jun 2016
Data monitoring committee
Yes

Publications

  • Petullo B, Wei L, Yereb M, Neal A, Rose J, Bekaii-Saab T, Wu C. A phase II study of biweekly pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinoma that have failed first-line platinum-based therapy. J Gastrointest Oncol. 2015 Jun;6(3):336-40. doi: 10.3978/j.issn.2078-6891.2015.011.

    PubMed 26029462

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pralatrexate, docetaxel and fludeoxyglucose F 18 in people with Adenocarcinoma of the Esophagus and Adenocarcinomas of the Gastroesophageal Junction, run by Ohio State University Comprehensive Cancer 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 19 inclusion and 6 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 1 Jun 2016. 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 16 Oct 2015). 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?

Overall Response (time frame: Approximately three years). 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 NCT01129206, 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 1 Jun 2016.

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