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Esophagogastric CancerPhase 2NCT02296671

Personalized Therapy for Esophagogastric Cancer Using Thymidylate Synthase Genetic Markers

A Phase 2 study testing Pemetrexed, Oxaliplatin and Leucovorin in people with Esophagogastric Cancer, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In this study the investigators aim to: 1) confirm the objective response rate (ORR) observed in the investigators initial study for patients with the TSER*2/*2 genotype 2) determine whether PEMOX regimen is more worthy of future development for this patient genotype selected population than FOLFOX based on the data… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophagogastric Cancer
What is being tested?
Pemetrexed, Oxaliplatin and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Feb 2015to Feb 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pre-Registration Inclusion Criteria
  • Histologically or cytologically confirmed unresectable or metastatic esophagogastric adenocarcinoma.
  • Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with CT scan, as >20 mm by chest x-ray, or >10 mm with calipers by clinical exam. PET/CT scan is acceptable as a substitute for a CT scan if the CT portion of the PET/CT is of identical diagnostic quality to a diagnostic CT scan.
  • At least 18 years of age.
  • ECOG performance status < 2
  • Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
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  • Registration Inclusion Criteria
  • TSER genotype *2/*2
  • ECOG performance status < 2
  • Normal bone marrow and organ function as defined below:
  • Absolute neutrophil count ≥ 1,500 cells/mm3
  • Platelets ≥ 100,000 cells/mm3
  • Total bilirubin < 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) < 3.0 x IULN
  • Creatinine within normal institutional limits OR Creatinine clearance ≥ 45 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

Who cannot join

  • Pre-Registration Exclusion Criteria
  • Prior therapy for this cancer.
  • A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with pemetrexed and/or oxaliplatin. 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.
  • Registration Exclusion Criteria
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  • Currently receiving any other investigational agents.
  • Known brain metastases. Patients with known brain metastases must 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.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed, 5-FU, leucovorin or oxaliplatin, or other agents used for premedication in the study.
  • Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry.

About this study

In this study the investigators aim to: 1) confirm the objective response rate (ORR) observed in the investigators initial study for patients with the TSER*2/*2 genotype 2) determine whether PEMOX regimen is more worthy of future development for this patient genotype selected population than FOLFOX based on the data indicating that pemetrexed may be a better TS targeted agent than 5-FU.

Patients who are homozygous for the TSER*2 allele (TSER*2/*2) will be able to continue in the study and will be randomized. Patients with other TSER genotypes will not be included and will be considered screen fails.

Read more

The first 8 patients with the TSER*2/*2 genotype will be randomized 1:1 to receive treatment with either PEMOX or FOLFOX (4 in each group).

Analysis of the objective response rate (ORR) in each treatment arm will occur after the first 8 patients are enrolled. Using the proposed Bayesian design, subsequent patients will be preferentially assigned to the "better performing" treatment arm based on continuous real-time reassessments of ORR results.

Being tested
Pemetrexed, Oxaliplatin, Leucovorin, Fluorouracil, Germline genotyping analyses for TSER

What participants receive

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

Study groups in NCT02296671
Study groupRoleWhat they receive
PEMOXExperimentalPemetrexed will be given intravenously (IV) on an outpatient basis on Day 1 of each 14-day cycle over 10 minutes. Oxaliplatin will be given (IV) on an outpatient basis on Day 1 of each 14-day cycle at a dose over 120 minutes. Drugs may be given in either order. -Oxaliplatin will be administered on Day 2 for Cycle 1 only. **
Receives: Drug: Pemetrexed; Drug: Oxaliplatin; Genetic: Germline genotyping analyses for TSER
FOLFOXExperimentalThe modified FOLFOX-6 regimen is the following drugs given every 14 days: * Oxaliplatin on Day 1 of each cycle * Leucovorin over 120 minutes on Day 1 of each cycle * 5-FU bolus and continuous infusion over 46 hours beginning on Day 1 of each cycle * Oxaliplatin will be administered on Day 2 for Cycle 1 only and the 5-FU infusion will be interrupted at 20 hours so that the FLT-PET scan can be performed (only for FLT-PET scan eligible patients).
Receives: Drug: Pemetrexed; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil; Genetic: Germline genotyping analyses for TSER

What is being measured

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

  1. Objective response rate (ORR)

    ORR=complete response + partial response by RECIST criteria

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Baseline, end of every 4th cycle, and end of treatment (estimated average of 6 months)

Secondary outcomes (2)

  1. Overall survival (OS)

    OS = The length of time from the start of treatment to time of death.

    Measured: Every 3 months for up to 4 years from the date of study registration or until death, whichever occurs first

  2. Quality of life

    Quality of life will be assessed by the EORTC QLQ-C30 and the EORTC QLQ-STO22

    Measured: Baseline and Day 1 of each cycle through Cycle 5 Day 1 (approximately Day 70)

Timeline

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

  1. First posted20 Nov 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionSep 2018 (estimated)
  4. Study completionFeb 2022 (estimated)

Why it stopped: Was unable to accrue any patients

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02296671
Sponsor's protocol ID
201412051
Status last verified
Mar 2016
First submitted
18 Nov 2014
Last updated
8 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Goff LW, Thakkar N, Du L, Chan E, Tan BR, Cardin DB, McLeod HL, Berlin JD, Zehnbauer B, Fournier C, Picus J, Wang-Gillam A, Lee W, Lockhart AC. Thymidylate synthase genotype-directed chemotherapy for patients with gastric and gastroesophageal junction cancers. PLoS One. 2014 Sep 18;9(9):e107424. doi: 10.1371/journal.pone.0107424. eCollection 2014.

    PubMed 25232828

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed, Oxaliplatin and Leucovorin in people with Esophagogastric Cancer, run by Washington University School of Medicine.

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 16 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: withdrawn, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Objective response rate (ORR) (time frame: Baseline, end of every 4th cycle, and end of treatment (estimated average of 6 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 NCT02296671, 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 8 Mar 2016.

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