Condition category
Cancer
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
12/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr N. Groeningen, van

ORCID ID

Contact details

VU Medical Center
Department of Medical Oncology
3 A 20
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 4441295
n.gronveld@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR470

Study information

Scientific title

Acronym

Vitamine study

Study hypothesis

Primary objective: Does supplementation of vitamins to the combination of gemcitabine and cisplatin increase the response rate in patients with oesophagogastric cancer?
Secondary objectives:
1. To assess the relationship between plasma homocysteine and plasma folic acid concentrations
2. To assess whether genetic polymorphisms in folate metabolising enzymes are related to folate homeostasis and efficacy
3. To determine the relationship between response and biomarkers for either gemcitabine and cisplatin
4. To determine whether vitamin supplementation affects pharmacokinetics of gemcitabine and cisplatin
5. To assess the time to progressive disease and overall survival
6. To assess the hematopoietic response of darbepoetin alfa

Ethics approval

Received from local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oesophagogastric cancer

Intervention

Group A: patients will be treated with gemcitabine 1250 mg/m2 IV on days 1 and 8 in combination with Cisplatin 80 mg/m2 on day 1 with vitamin supplementation (Folic acid 450 ug/24 hours PO, starting at least one week prior to chemotherapy and finishing at least 3 weeks after the last treatment dose. Vitamin B12 1000 ug approximately every 9 weeks, starting 1 week before chemotherapy and finishing at least 3 weeks after the last treatment dose).
Group B: patients will be treated with gemcitabine 1250 mg/m2 on days 1 and 8 in combination with Cisplatin 80 mg/m2 on day 1 without vitamin supplementation. Cycles will be administered every 21 days. A maximum of 6 cycles will be administered to every patient, although this number could be increased if the patient may benefit from it, based on investigator's criteria.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Response rate

Secondary outcome measures

1. Time to progression
2. Overall survival

Overall trial start date

01/03/2004

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

82

Participant 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

Recruitment start date

01/03/2004

Recruitment end date

01/03/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Centre (Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Eli Lilly Nederland B.V. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Amgen B.V. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

VU University Medical Center (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes