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

NCT ID: NCT01716546

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-01-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Panitumumab plus DCF

Group Type: EXPERIMENTAL

Pazopanib

Intervention Type: DRUG

Interventions

Pazopanib

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

"IASO" General Hospital of Athens

Athens, , Greece

401 Military Hospital of Athens

Athens, , Greece

Air Forces Military Hospital of Athens

Athens, , Greece

"Ag.Georgios" General Hospital of Chania

Chania, , Greece

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

Heraklion, , Greece

State General Hospital of Larissa

Larissa, , Greece

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

Piraeus, , Greece

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

Thessaloniki, , Greece

Diabalkaniko General Hospital of Thessaloniki

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

CT/09.10

Identifier Type: -

Identifier Source: org_study_id