AzTrials
AzTrials

Gastroesophageal Junction AdenocarcinomaPhase 2NCT00515411

Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Docetaxel, Leucovorin, Fluorouracil, Cisplatin, Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen and Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab in people with Gastroesophageal Junction Adenocarcinoma and Gastric Cancer, run by Memorial Sloan Kettering Cancer Center at 15 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

Chemotherapy given together is a standard way to treat your cancer. One standard treatment includes a combination of docetaxel, cisplatin, and fluorouracil. However, the original combination of these three drugs can cause many side effects. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Docetaxel, Leucovorin, Fluorouracil, Cisplatin, Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen and Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
15 sitesUnited States
Study dates
23 Oct 2006to 26 Oct 2018
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

  • Patients must have histologically or cytologically confirmed metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. GEJ adenocarcinoma may be classified according to Siewert's classification type I, II, or III[43].
  • Histological documentation of local recurrence or metastasis is strongly encouraged, unless the risk of such a procedure outweighs the potential benefit of confirming the metastatic disease.
  • If no histologic confirmation, then the metastases or recurrence will require documentation by a 2nd radiographic procedure (eg. PET/CT scan or MRI in addition to the CT scan). If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation will be required.
  • Patients must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease. Measurable disease is defined as that which can be measured in at least one dimension as > 20 mm with conventional techniques, or >10 mm by high resolution imaging. Disease that is identified on radiology studies, but does not meet the criteria for measurable disease, is considered non-measurable.
  • Patients may have received no prior chemotherapy for metastatic or unresectable disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration. Patients may not have received prior docetaxel or cisplatin.
  • Age 18 years or older.
Show all 26Show fewer
  • Karnofsky performance status > than or = to 70% (ECOG performance status 0-1).
  • Peripheral neuropathy < than or = to grade 1.
  • Hematologic (minimal values):
  • White blood cell count > than or = to 3000/mm3
  • Absolute neutrophil count > than or = to 1500 cells/ mm3
  • Hemoglobin > than or = to 9.0 g/dl
  • Platelet count > than or = to 100,000 / mm3
  • Hepatic (minimal values):
  • Total bilirubin < or = to 1.5
  • * AST and ALT and Alkaline phosphatase must be within the eligible range. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used. Patients with alkaline phosphatase elevation secondary to the bony metastases rather than liver dysfunction may proceed with treatment on protocol after discussion with the principal investigator.
  • Kidney function (minimal values):
  • Serum creatinine < than or = to 1.5 mg/dl - if serum creatinine is 1.2-1.5 mg/dl, the creatinine clearance (either measured or calculated) must be 50 ml/min or greater
  • The patient has a PT (INR) < than or = to 1.5 and an PTT < than or = to 3 seconds above the upper limits of normal if the patient is not on anticoagulation. If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
  • The patient must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of LMW heparin
  • The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices)
  • Women of childbearing potential have a negative pregnancy test.
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
  • Ability to understand informed consent and signing of written informed consent document prior to initiation of protocol therapy.
  • Patients must have HER2-positive (FISH+ or IHC 3+) metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma to be eligible for trastuzumab. For the purposes of this protocol, FISH+ is defined as HER2:CEP17 ratio ≥ 2.0. Biopsy samples with cohesive IHC3+ or FISH+ clones are considered HER2 positive irrespective of size, i.e.<10%. FISH+ defined as >2 HER2:CEP17.
  • Patients who are receiving trastuzumab must have a left ventricular ejection fraction of ≥ 50%.

Who cannot join

  • Patients who have received previous chemotherapy for the treatment of metastatic or unresectable gastric or GEJ adenocarcinoma are ineligible.
  • Patients who have received previous pre- or post-operative chemotherapy or chemoradiation are ineligible if therapy was completed less than 6 months prior to study registration. Patients must have recovered from adverse events from any previous therapy.
  • Patients who have received previous docetaxel or cisplatin.
  • Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
  • Patients with brain or central nervous system metastases, including leptomeningeal disease.
  • Pregnant (positive pregnancy test) or breast feeding.
Show all 18Show fewer
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Significant cardiac disease as defined as:
  • unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months
  • Evidence of bleeding diathesis or coagulopathy.
  • History of a stroke or CVA within 6 months
  • Clinically significant peripheral vascular disease.
  • Clinically significant hearing loss or ringing in the ears.
  • Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
  • Inability to comply with study and/or follow-up procedures.
  • Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
  • For patients who are Her2 positive and will be treated on the trastuzumab + mDCF cohort, prior trastuzumab treatment is not allowed.
  • For patients who are Her2 positive and will be treated on the trastuzumab+mDCF cohort, left ventricular function <50%

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Piedmont Hospital Research Institute

    Atlanta, Georgia, 30309

  • Memoral Sloan Kettering Cancer Center

    Basking Ridge, New Jersey

  • University Hospital of Cleveland

    Cleveland, Ohio, 44106

  • Memorial Sloan-Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • City of Hope Cancer Center

    Duarte, California, 91010

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Memorial Sloan Kettering Cancer Center 1275 York Avenue

    New York, New York, 10065

  • Nebraska Cancer Specialists, Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Memorial Cancer Institute

    Pembroke Pines, Florida, 33025

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York

  • Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital

    Sleepy Hollow, New York

Other trials in United States

About this study

Official title: A Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Patients With Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

Chemotherapy given together is a standard way to treat your cancer. One standard treatment includes a combination of docetaxel, cisplatin, and fluorouracil. However, the original combination of these three drugs can cause many side effects. This study is being done to find out if these three drugs can be given at lower doses more often, with fewer side effects and still maintain the same benefit as the standard way of giving this three drug combination. If your tumor overexpresses a protein called Her2, you are also eligible to receive trastuzumab with chemotherapy. Trastuzumab is a medicine that has been approved by the US Food and Drug Administration for the treatment of Her2 positive breast cancer. Trastuzumab is now also a standard treatment in combination with chemotherapy for the treatment of Her2 positive stomach cancer. If your tumor is Her2 positive, you would receive the modified administration schedule of docetaxel, cisplatin, and fluorouracil with trastuzumab.

Being tested
Docetaxel, Leucovorin, Fluorouracil, Cisplatin, Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen, Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab
Keywords
gastroesophageal junction, gastric cancer, adenocarcinoma, unresectable gastric cancer, metastatic gastric
Medical subject headings
Stomach Neoplasms, Adenocarcinoma

What participants receive

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

  • Docetaxel, Leucovorin, Fluorouracil, CisplatinDrug

    Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)

  • Docetaxel, Cisplatin, Fluorouracil, Neulasta, or NeupogenDrug

    Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17

    • 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg

    Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.

  • Docetaxel, Leukvorin, Flurouracil, Cisplatin, TrastuzumabDrug

    Treatment for Her2 Positive Participants

    Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.

Study groups in NCT00515411
Study groupRoleWhat they receive
Arm A, - Modified DCFActive comparatorDrug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).
Receives: Drug: Docetaxel, Leucovorin, Fluorouracil, Cisplatin
ARM B - Parent DCF with G-CSFActive comparatorDocetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17 * 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg
Receives: Drug: Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen
Arm C - Modifid DCF + TrastuzumabActive comparatorTreatment for Her2 Positive Participants Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.
Receives: Drug: Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab

What is being measured

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

  1. 6 Month 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", or similar definition as accurate and appropriate

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Secondary outcomes (1)

  1. Overall Survival

    Overall survival measured in months

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 43 months

Timeline

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

  1. First posted13 Aug 2007 (estimated)
  2. Study start23 Oct 2006
  3. Primary completion26 Oct 2018
  4. Study completion26 Oct 2018

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
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00515411
Sponsor's protocol ID
06-103
Status last verified
Oct 2018
First submitted
10 Aug 2007
Last updated
10 Dec 2019
Data monitoring committee
Yes

Publications

  • Mondaca S, Margolis M, Sanchez-Vega F, Jonsson P, Riches JC, Ku GY, Hechtman JF, Tuvy Y, Berger MF, Shah MA, Kelsen DP, Ilson DH, Yu K, Goldberg Z, Epstein AS, Desai A, Chung V, Chou JF, Capanu M, Solit DB, Schultz N, Janjigian YY. Phase II study of trastuzumab with modified docetaxel, cisplatin, and 5 fluorouracil in metastatic HER2-positive gastric cancer. Gastric Cancer. 2019 Mar;22(2):355-362. doi: 10.1007/s10120-018-0861-7. Epub 2018 Aug 7.

    PubMed 30088161

  • Shah MA, Janjigian YY, Stoller R, Shibata S, Kemeny M, Krishnamurthi S, Su YB, Ocean A, Capanu M, Mehrotra B, Ritch P, Henderson C, Kelsen DP. Randomized Multicenter Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (DCF) Versus DCF Plus Growth Factor Support in Patients With Metastatic Gastric Adenocarcinoma: A Study of the US Gastric Cancer Consortium. J Clin Oncol. 2015 Nov 20;33(33):3874-9. doi: 10.1200/JCO.2015.60.7465.

    PubMed 26438119

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Leucovorin, Fluorouracil, Cisplatin, Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen and Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab in people with Gastroesophageal Junction Adenocarcinoma and Gastric Cancer, run by Memorial Sloan Kettering Cancer Center at 15 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 26 inclusion and 18 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 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 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 10 Dec 2019). 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?

6 Month Progression Free Survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 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 NCT00515411, which also lists 2 linked publications.

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 10 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in