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Gastric CancerPhase 1/2NCT01716546

Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric Cancer

A Phase 1/2 study testing Pazopanib in people with Gastric Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Investigators propose to study the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients with advanced cancer of the stomach. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Gastric Cancer
What is being tested?
Pazopanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
9 sitesGreece
Study dates
Jul 2011to Jan 2015
Phase
Phase 1/2
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
  • Patient's age between 20 and 70 years old
  • Measurable disease defined by RECIST criteria
  • Patients with non-measurable disease could be enrolled in the phase I part of the study
  • ECOG performance status ≤ 1
  • Hgb ≥ 8g/dL, WBC ≥ 3 x 109/L , neutrophils count ≥ 1.5 x 109/L , platelets ≥100 x 109/L, Creatinine clearance ≥50 mL/min, Total bilirubin ≤ 1.5 X UNL, AST, ALT and ALP ≤ 2.5 x UNL
Show all 9Show fewer
  • No prior chemotherapy or more than 6 months from adjuvant chemotherapy or chemo-radiation
  • Estimated life expectancy more than 3 months
  • Written informed consent

Who cannot join

  • Gastrointestinal bleeding
  • Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
  • CNS metastases
  • History of hypersensitivity to fluoropyrimidines, docetaxel or platinum compounds
  • Any previous chemotherapy or radiotherapy for advanced disease
  • Patient pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
Show all 16Show fewer
  • Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
  • Known hypersensitivity reaction to the component of the treatment
  • Active infection or malnutrition or bowel obstruction
  • Legal incapacity or limited legal capacity
  • Definite contraindications for the use of corticosteroids
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
  • Chronic inflammation of the bowel
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
  • Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
  • A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Greece9 sites

  • "IASO" General Hospital of Athens

    Athens

  • 401 Military Hospital of Athens

    Athens

  • Air Forces Military Hospital of Athens

    Athens

  • "Ag.Georgios" General Hospital of Chania

    Chania

  • University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece

    Heraklion

  • State General Hospital of Larissa

    Larissa

  • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

    Piraeus

  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

    Thessaloniki

  • Diabalkaniko General Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

About this study

Official title: Phase I/II, Multicenter, Single-Arm Clinical Trial of Panitumumab in Combination With Cisplatin, Fluourouracil and Docetaxel (DCF) in Locally Advanced or Metastatic Cancer of the Stomach and Gastro-oesophageal Junction.

Investigators propose to study the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients with advanced cancer of the stomach.

Read the detailed description

Investigators propose a phase I/II study in order to evaluate the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in chemotherapy - naive patients with advanced cancer of the stomach.

Investigators hypothesize that the addition of panitumumab to DCF regimen in advanced cancer of the stomach and gastroesophageal junction is feasible, well tolerated and could achieve an objective response rate of greater than 40%.

The 2-weekly schedule of DCF will be used as chemotherapy since a recently presented trial demonstrated a comparable efficacy but a more favourable toxicity profile comparable to the 3-weekly schedule.

Conditions
Gastric Cancer
Being tested
Pazopanib
Keywords
Advanced cancer of the stomach, Chemotherapy - naive patients, DCF
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • PazopanibDrug

    Also called Pazopanib: 800mg once a day for up to 2 years from date of first dose

Study groups in NCT01716546
Study groupRoleWhat they receive
1ExperimentalPanitumumab plus DCF
Receives: Drug: Pazopanib

What is being measured

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

  1. Objective response rate

    Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression

    Measured: Every 8 weeks

Secondary outcomes (3)

  1. Progression Free Survival

    Patients will be evaluated from the date of the first chemotherapy cycle until the date of first documented progression or date of death from any cause, whichever came first

    Measured: 1 year

  2. Overall Survival

    Patients will be evaluated for overall survival from the date of the first chemotherapy cycle until the date of death from any cause

    Measured: 1 year

  3. Maximum Tolerated Dose of the combination

    Patients will be evaluated for toxicity profil on Day 1 of the first two chemotherapy cycle (cycle repeated every 2 weeks)

    Measured: Up to 4 weeks

Timeline

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

  1. First posted30 Oct 2012 (estimated)
  2. Study startJul 2011
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: Not reached the primary endpoint target according to the statistical design

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01716546
Sponsor's protocol ID
CT/09.10
Status last verified
Oct 2015
First submitted
2 Oct 2012
Last updated
8 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pazopanib in people with Gastric Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.

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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Greece. 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?

The study was stopped early (reason given: Not reached the primary endpoint target according to the statistical design). Results are not available in the source record.

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 (time frame: Every 8 weeks). 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 NCT01716546.

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 Oct 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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