NCT01716546

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1 gastric-cancer

Timeline
Completed

Started Jul 2011

Typical duration for phase_1 gastric-cancer

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

3.5 years

First QC Date

October 2, 2012

Last Update Submit

October 7, 2015

Conditions

Gastric Cancer

Keywords

Advanced cancer of the stomachChemotherapy - naive patientsDCF

Outcome Measures

Primary Outcomes (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

    Every 8 weeks

Secondary Outcomes (3)

  • Progression Free Survival

    1 year

  • Overall Survival

    1 year

  • Maximum Tolerated Dose of the combination

    Up to 4 weeks

Study Arms (1)

1

EXPERIMENTAL

Panitumumab plus DCF

Drug: Pazopanib

Interventions

PazopanibDRUG
Also known as: Pazopanib: 800mg once a day for up to 2 years from date of first dose
1

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • No prior chemotherapy or more than 6 months from adjuvant chemotherapy or chemo-radiation
  • Estimated life expectancy more than 3 months
  • Written informed consent

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

"IASO" General Hospital of Athens

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

"Ag.Georgios" General Hospital of Chania

Chania, Greece

Location

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

Heraklion, Greece

Location

State General Hospital of Larissa

Larissa, Greece

Location

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

Piraeus, Greece

Location

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

Thessaloniki, Greece

Location

Diabalkaniko General Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 30, 2012

Study Start

July 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

GR(9)