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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.


Phase 1/Phase 2
20 Years
70 Years
Open (Enrolling)
Both
Gastric Cancer

Thank you

Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Description:

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

Outcome Time Frame:

Every 8 weeks

Safety Issue:

No

Authority:

Greece: National Organization of Medicines

Study ID:

CT/09.10

NCT ID:

NCT01716546

Start Date:

July 2011

Completion Date:

July 2014

Related Keywords:

  • Gastric Cancer
  • Advanced cancer of the stomach
  • Chemotherapy - naive patients
  • DCF
  • Stomach Neoplasms

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