A randomised phase II study evaluating weekly docetaxel, cisplatin, fluoropyrimidine (wTCF) plus or minus panitumumab in advanced oesophago-gastric cancer.

Phase 2

Completed

• Conditions: Cancer - Oesophageal (gullet); Metastatic or locally recurrent oesophago-gastric cancer; Cancer - Stomach

• Registration Number: ACTRN12609000109202
• Lead Sponsor: AGITG -Australasian Gastro-Intestinal Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-17
• Study Completion: 2012-12-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

a)Age over 18.
b)Histological diagnosis of metastatic or locally recurrent oesophago-gastric cancer (squamous cell, adenocarcinoma or undifferentiated carcinoma)
c)Any primary oesophago-gastric site (oesophagus, oesophago-gastric junction (OGJ) or stomach)
d)Unidimensional measurable disease as assessed by computed tomography (CT) scan (RECIST v1.1 criteria). There must be at least one lesion > or equal to 20mm as measured by conventional computed tomography (CT) scan or > or equal to 10mm as measured by spiral computed tomography (CT) scan. All sites of disease must have been evaluated within 21 days of initiating study treatment and diagnosed by the investigator.
e)Prior palliative radiotherapy is allowed provided no concurrent chemotherapy was administered, all radiation toxicities have resolved to grade 1 or less and at least 14 days has elapsed from the last dose of radiotherapy until the start of chemotherapy in ATTAX 3. Furthermore, the site(s) of measurable disease must include at least one that is outside the radiation field unless this site has demonstrated clear progression, prior to randomisation.
f)World Health Organisation (WHO) performance status 0, 1 or 2 (Patients who ahave a performance status (PS) 2 should have serum albumin >30 g/L)
g)Able to swallow tablets if planned to receive capecitabine
h)Adequate bone marrow function with platelets>100x109/L; neutrophils>1.5x109/L and haemoglobin = 9.0g/dL.
i)Adequate renal function, with calculated creatinine clearance >50 ml/min based on the Cockcroft-Gault method. Adequate renal function (measured creatinine clearance>50ml/min) assessed by 24 hour urine or glomerular filtration rate (GFR) scan is also acceptable in cases where the Cockcroft-Gault method is considered inaccurate.
j)Adequate electrolytes, with serum magnesium level within the normal range and corrected serum calcium within the normal range.
k)Adequate hepatic function with serum total bilirubin <1.25 x upper limit of normal range and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <2.5x upper limit of normal range and alkaline phosphatase <5x upper limit of normal range
l)Life expectancy of at least 12 weeks
m)Negative pregnancy test and adequate contraceptive precautions if relevant
n)Written informed consent for main study AND tissue banking

Exclusion Criteria

a)Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or comply with the study protocol.
b)Previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix or other cancers treated with curative intent > 2 years previously and without evidence of relapse.
c)Uncontrolled metastatic disease to the central nervous system. Central Nervous System (CNS) metastases should be treated with surgery and/or radiotherapy and the patient should have stable neurology on a stable dose of steroids for at least 2 weeks.
d)Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues.
e)Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g. cetuximab) or treatment with small molecule epidermal growth factor receptor (EGFR) inhibitors (e.g. erlotinib).
f)Prior chemotherapy agents for metastatic or recurrent disease. Neoadjuvant or adjuvant chemotherapy given alone or with concurrent radiotherapy > 12 months ago for oesophago-gastric cancer is allowed.
g)History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline computed tomography (CT) chest scan.
h)Known dihydropyrimidine dehydrogenase (DPD) deficiency.
i)Pregnancy or breast feeding (All women of childbearing potential must have a negative pregnancy test prior to inclusion into the trial).
j)Men or women of childbearing potential (women who are post-menopausal < 52 weeks, not surgically sterilised, or not abstinent) not consenting to use adequate contraception (per institutional standard of care) during the study and after the last investigational product (s) administration (24 weeks for women, 4 weeks for men).
k)Clinical evidence of >grade 2 peripheral neuropathy, ie. affecting activities of daily living
l)Any uncontrolled concurrent medical condition
m)Patients with known malabsorption syndromes (if planning to receive capecitabine).
n)Known allergy to the investigational product, to any of its excipients, to monoclonal antibodies, or to any of the components of the chemotherapy regimen
o)Any co-morbid disease that would increase risk of toxicity
p)Participation in any investigational drug study within the previous 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the response rates of wTCF given with or without panitumumab in the treatment of patients with metastatic or locally recurrent oesophago-gastric cancer.[Treatment will continue for 24 weeks and tumour response will be assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) guidelines. Assessments will be carried out every 6 weeks during treatment and 12 weekly thereafter until disease progression, and then according to best-practice until death.]