Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

NCT01379807 | Unknown Phase 2

• 1 other identifier: GGIO-2010-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 9

Brief Summary

The clinical hypothesis of this study is that the addition of Panitumumab to the first line treatment combination of docetaxel plus cisplatin will provide benefit to patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  To estimate the objective response rate in patients treated with docetaxel, cisplatin and panitumumab as first-line treatment in advanced gastric or gastroesophageal junction adenocarcinoma.

  3 years

Secondary Outcomes (10)

• Disease control rate

  3 years

• Duration of response

  3 years

• Time to response

  3 years

• Time to progression

  3 years

• Time to treatment failure

  3 years

Study Arms (1)

panitumumab + docetaxel + cisplatino

EXPERIMENTAL

Drug: panitumumab + docetaxel + cisplatino

Interventions

panitumumab + docetaxel + cisplatino DRUG

Panitumumab, docetaxel and cisplatin combination treatment will be administered for 6 months or until disease progression (PD) according to investigator's criteria unacceptable toxicity or consent withdrawal.

panitumumab + docetaxel + cisplatino

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with advanced unresectable or metastatic disease.
• Measurable disease per the revised RECIST (Response Evaluation Criteria in Solid Tumor) Guidelines
• ECOG performance score of 0 - 2
• Within seven days prior to initiating study treatment:Haematology:Neutrophils ≥ 1.5x109, Platelets ≥ 100x10/ L, Hemoglobin ≥ 9g/dL. Hepatic functions: Total bilirubin ≤ 1.5 time the upper normal limit (UNL),ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases,ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases. Renal function: creatinine clearance ≥50 mL/min. Metabolic Function: Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal.

You may not qualify if:

• Prior chemotherapy or other anticancer therapy for advanced unresectable or metastatic disease (1st line)
• Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR inhibitors (e.g. erlotinib).
• HER2-positive tumor (centrally assessed)
• Past or current history (within the last 5 years prior to treatment start) of other malignancies except gastric cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)
• Current or prior history of central nervous system metastases
• Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
• Known hypersensitivity to any of the study drugs
• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
• History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
• Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
• Subject (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.

Sponsors & Collaborators

• Grupo Gallego de Investigaciones Oncologicas: lead
• Amgen: collaborator
• Trial Form Support S.L.: collaborator

Study Sites (9)

Complejo Hospitalario Universitario de A Coruña

A Coruña, La Coruña, 15006, Spain

Location

Centro Oncológico de Galícia

A Coruña, La Coruña, 15009, Spain

Location

Hospital Arquitecto Mercide

Ferrol, La Coruña, 15405, Spain

Location

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

Location

Complejo Hospitalario Ourense

Ourense, Ourense, 32005, Spain

Location

Hospital de Pontevedra

Pontevedra, Pontevedra, 36002, Spain

Location

Complejo Hospitalario Universitario de Vigo (Xeral Cies)

Vigo, Pontevedra, 36204, Spain

Location

Policlínica de Vigo S.A.

Vigo, Pontevedra, 36211, Spain

Location

MeSH Terms

Interventions

Panitumumab; Docetaxel; Cisplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 23, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 11, 2015

Record last verified: 2011-04

Locations

ES (9)