Stomach NeoplasmsPhase 2FOLFIRINOXNCT01928290
Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer
A Phase 2 study testing Irinotecan, Trastuzumab and Oxaliplatin in people with Stomach Neoplasms and Esophageal Neoplasms, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This phase II trial studies how well combination chemotherapy works in treating patients with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms, Esophageal Neoplasms
- What is being tested?
- Irinotecan, Trastuzumab and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2013to 28 Oct 2019
- 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
- Biopsy-proven and inoperable locally advanced, recurrent, or metastatic cancer of the esophagus, stomach, or gastro-esophageal junction.
- 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.
- Prior single modality radiation therapy is allowed.
- At least 18 years of age.
- ECOG performance status ≤ 2
- Normal bone marrow and organ function as defined below:
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- Absolute neutrophil count ≥ 1,500/mcl
- Platelets ≥ 100,000/mcl
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
- Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- LVEF ≥ 50%
- 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.
- Ability to understand and willingness to sign an IRB approved written informed consent document (legally authorized representative is allowed).
- Patients already receiving treatment with FOLFIRINOX +/- trastuzumab may participate in the study and have their data collected retrospectively if they met inclusion criteria at the start of therapy and sign consent for study participation moving forward.
- Both men and women and members of all races and ethnic groups are eligible for this trial.
Who cannot join
- Chemotherapy in the 6 months prior to registration.
- Any active malignancy within 3 years that may alter the course of esophageal cancer (Apparently cured localized malignancy or advanced, but indolent malignancy with significantly more favorable prognosis are allowed)
- Receiving any other investigational agents at the time of registration.
- Known untreated brain metastases. These patients 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 the agents used in the study.
- Previous therapy for metastatic gastroesophageal cancer. Previous perioperative chemotherapy is allowed as long as the duration without treatment has been greater than 6 months..
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- A history of congestive heart failure, transmural myocardial infarction, symptomatic valvular disease, or high-risk arrhythmia.
- 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.
- Pregnant and/or breastfeeding. Patient must have a negative urine pregnancy test within 14 days of study entry.
- Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with trastuzumab. 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.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase II Study of FOLFIRINOX Chemotherapy for Treatment of Advanced Gastric, Gastro-esophageal Junction, and Esophageal Tumors
This phase II trial studies how well combination chemotherapy works in treating patients with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
- Conditions
- Stomach Neoplasms, Esophageal Neoplasms
- Being tested
- Irinotecan, Trastuzumab, Oxaliplatin, Leucovorin, Fluorouracil
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called Camptosar®, CPT-11
TrastuzumabDrug
Also called Herceptin®
OxaliplatinDrug
Also called Eloxatin®
LeucovorinDrug
Also called Wellcovorin® I.V., citrovorum factor
FluorouracilDrug
Also called folinic acid, 5-formyl tetrahydrofolate, Adrucil® Injection, 5-Fluorouracil
| Study group | Role | What they receive |
|---|---|---|
| Arm A: FOLFIRINOX (HER2-negative) | Experimental | Irinotecan 180 mg/m2 IV on Days 1 \& 15.
Oxaliplatin 85 mg/m2 IV on Days 1 \& 15.
Leucovorin 400 mg/m2 IV on Days 1 \& 15.
Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15. Receives: Drug: Irinotecan; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Experimental | Trastuzumab 8 mg/kg on Cycle 1 Day 1 then 4 mg/kg on Day 15 and Day 1 of all future cycles.
Irinotecan 180 mg/m2 IV on Days 1 \& 15.
Oxaliplatin 85 mg/m2 IV on Days 1 \& 15.
Leucovorin 400 mg/m2 IV on Days 1 \& 15.
Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15. Receives: Drug: Irinotecan; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Objective Response
- Objective response (defined as complete response (CR) + partial response (PR) by RECIST 1.1 criteria)
- CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
- PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Through completion of treatment (estimated to be 4 months)
Secondary outcomes (6)
Progression Free Survival
Duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
Time to Progression (TTP)
Duration of time from start of treatment to time of progression. Progression is defined as At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
Overall Survival (OS)
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Measured: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
Clinical Benefit Rate
- Clinical benefit rate is the percentage of combined patients who have achieved complete response (CR), partial response (PR), and stable disease (SD)
- CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm
- PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
- SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Through completion of treatment (estimated to be 4 months)
Duration of Response
Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented
Measured: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events
Measured: 30 days after completion of treatment (estimated to be 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study start8 Nov 2013
- Primary completion3 Dec 2018
- Study completion28 Oct 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haeseong Park, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928290
- Sponsor's protocol ID
- 201309035
- Acronym
- FOLFIRINOX
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2013
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park H, Jin RU, Wang-Gillam A, Suresh R, Rigden C, Amin M, Tan BR, Pedersen KS, Lim KH, Trikalinos NA, Acharya A, Copsey ML, Navo KA, Morton AE, Gao F, Lockhart AC. FOLFIRINOX for the Treatment of Advanced Gastroesophageal Cancers: A Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1231-1240. doi: 10.1001/jamaoncol.2020.2020.
PubMed 32469386
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of FOLFIRINOX Chemotherapy for Treatment of Advanced Gastric, Gastro-esophageal Junction, and Esophageal Tumors
- ClinicalTrials.gov ID
- NCT01928290
- Acronym / sponsor ID
- FOLFIRINOX / 201309035
- Conditions
- Stomach Neoplasms, Esophageal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 8 Nov 2013 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well combination chemotherapy works in treating patients with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: FOLFIRINOX (HER2-negative) | Experimental | Drug: Irinotecan, Drug: Oxaliplatin, Drug: Leucovorin, Drug: FluorouracilIrinotecan 180 mg/m2 IV on Days 1 \& 15. Oxaliplatin 85 mg/m2 IV on Days 1 \& 15. Leucovorin 400 mg/m2 IV on Days 1 \& 15. Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15. |
| Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) | Experimental | Drug: Irinotecan, Drug: Trastuzumab, Drug: Oxaliplatin, Drug: Leucovorin, Drug: FluorouracilTrastuzumab 8 mg/kg on Cycle 1 Day 1 then 4 mg/kg on Day 15 and Day 1 of all future cycles. Irinotecan 180 mg/m2 IV on Days 1 \& 15. Oxaliplatin 85 mg/m2 IV on Days 1 \& 15. Leucovorin 400 mg/m2 IV on Days 1 \& 15. Fluorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Biopsy-proven and inoperable locally advanced, recurrent, or metastatic cancer of the esophagus, stomach, or gastro-esophageal junction.
- 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.
- Prior single modality radiation therapy is allowed.
- At least 18 years of age.
- ECOG performance status ≤ 2
Key exclusion criteria (10 listed)
- Chemotherapy in the 6 months prior to registration.
- Any active malignancy within 3 years that may alter the course of esophageal cancer (Apparently cured localized malignancy or advanced, but indolent malignancy with significantly more favorable prognosis are allowed)
- Receiving any other investigational agents at the time of registration.
- Known untreated brain metastases. These patients 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 the agents used in the study.
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 |
|---|---|---|
| IrinotecanAlso: Camptosar®, CPT-11 | Drug | Arm A: FOLFIRINOX (HER2-negative), Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) |
| TrastuzumabAlso: Herceptin® | Drug | Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) |
| OxaliplatinAlso: Eloxatin® | Drug | Arm A: FOLFIRINOX (HER2-negative), Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) |
| LeucovorinAlso: Wellcovorin® I.V., citrovorum factor | Drug | Arm A: FOLFIRINOX (HER2-negative), Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) |
| FluorouracilAlso: folinic acid, 5-formyl tetrahydrofolate, Adrucil® Injection, 5-Fluorouracil | Drug | Arm A: FOLFIRINOX (HER2-negative), Arm B: FOLFIRINOX & Trastuzumab (HER2-positive) |
Primary outcome
Number of Participants With an Objective Response
Time frame: Through completion of treatment (estimated to be 4 months)
* Objective response (defined as complete response (CR) + partial response (PR) by RECIST 1.1 criteria) * CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
6 secondary outcomes
Progression Free Survival
Time frame: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
Time to Progression (TTP)
Time frame: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
Overall Survival (OS)
Time frame: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
Clinical Benefit Rate
Time frame: Through completion of treatment (estimated to be 4 months)
Duration of Response
Time frame: Through 1 year after completion of treatment (median follow-up 16.2 months - 95% CI 4.7-42.5 months)
Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events
Time frame: 30 days after completion of treatment (estimated to be 5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32469386Park H, Jin RU, Wang-Gillam A, Suresh R, Rigden C, Amin M, Tan BR, Pedersen KS, Lim KH, Trikalinos NA, Acharya A, Copsey ML, Navo KA, Morton AE, Gao F, Lockhart AC. FOLFIRINOX for the Treatment of Advanced Gastroesophageal Cancers: A Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1231-1240. doi: 10.1001/jamaoncol.2020.2020.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Haeseong Park, M.D. principal investigator
Washington University School of Medicine
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 Irinotecan, Trastuzumab and Oxaliplatin in people with Stomach Neoplasms and Esophageal Neoplasms, run by Washington University School of Medicine 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 15 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 25 Aug 2020. 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 18 Jan 2020). 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?
Number of Participants With an Objective Response (time frame: Through completion of treatment (estimated to be 4 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 NCT01928290, 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 25 Aug 2020.