Chemotherapy +/- vitamin supplementation in advanced Oesophagogastric cancer

Completed

• Conditions: Oesophagogastric cancer; Cancer; Malignant neoplasm of stomach

• Registration Number: ISRCTN77284975
• Lead Sponsor: VU University Medical Centre (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Patients must have histologically or cytologically confirmed metastatic or locally advanced unresectable advanced oesophagogastric carcinoma (squamous or adenocarcinoma), not amenable for curative treatment
2. Patients may have received prior surgery, and chemotherapy and/or radiotherapy in neo-adjuvant or adjuvant setting as long as the chemotherapy was completed at least 6 months prior to study entry
3. Patients should have measurable disease according to RECIST criteria
4. Age of at least 18
5. Performance status (ECOG) 0, 1 or 2
6. Life expectancy of at least 12 weeks
7. Adequate bone marrow function, defined by a neutrophil count above 1.5 x 10^9/l, platelet count above 100 x 10^9/l and hemoglobin above 5.6 mmol/l
8. Adequate renal and hepatic function, defined by bilirubin <1.5 x upper limit of normal (ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) <3 x ULN (<5 x ULN is acceptable in case of liver metastasis) and creatinine <120 umol/l and/or creatinine clearance >60 ml/min (calculated by using the Cockcroft and Gault formula)
9. Patients must not already be taking vitamin supplements as defined in the protocol
10. Patients with childbearing potential must use an adequate contraceptive method
11. Patients must be able to comply with protocol procedures, able to swallow pills and have adequate geographical proximity to the study site
12. Patients must sign written informed consent

Exclusion Criteria

1. Active infection or cardiac disease, at the investigator?s criteria
2. Pregnancy or breast-feeding
3. Known symptomatic metastasis in the central nervous system (CNS)
4. Treatment with any investigational agent in the month prior to inclusion
5. Other serious disease, at the investigator?s discretion
6. Prior diagnosis of other malignant disease, excluding adequately treated in situ carcinoma of the cervix and skin cancer other than melanoma, low grade prostate carcinoma (gleason score <6) or any other non-relapsed malignancy that was treated more than five years before diagnosis
7. Received any RBC transfusions within 14 days before first dose of Aranesp or received rHuEPO or darbepoetin alfa therapy within 4 weeks before study day 1

Study & Design

• Study Type: Interventional
• Study Design: Not specified