Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.

Metastatic Colorectal Cancer Clinical Trial

Official title:

Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469480
• Other study ID #: FERINJECT
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: August 2020

Study information

• Verified date: October 2020
• Source: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%. About 70% of these patients suffer from iron deficiency anemia (IDA) which adds both physical and cognitive impediments to an already straining chemotherapy. Moreover, a chronic disease like cancer often results in a reduced availability of iron for the body. In clinical practice iron substitution is usually administered orally. Due to low resorption rates, frequent gastric side effects and thus poor patient compliance a parenteral substitution seems to be a better option in terms of efficacy. In the framework of a randomized multicenter clinical trial ('FerInject') a comparison of efficacy parameters of parenteral vs. oral iron substitution will now be conducted in order to identify the best treatment form for clinical practice in oncology. Furthermore detailed quality of life-data (QoL) will be collected in both treatment arms for effect comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Metastatic or inoperable colorectal carcinoma. No curative therapy available.

2. Current palliative chemotherapy. Patients under conversion therapy must not be enrolled to this study.

3. Iron deficiency anemia: hemoglobin = 10.5 g/dl and transferrin saturation < 20 % and/or serum ferritin < 20 ng/ml

4. Male and female patients aged = 18 years; maturity

5. ECOG = 2

6. Written informed consent

7. Life expectancy > 6 months

8. Body weight = 40 kg

Exclusion Criteria:

1. Oral or intravenous iron substitution within the last 4 weeks

2. Age < 18 years or body weight < 40 kg

3. Absorption dysfunction due to short bowel syndrome or after gastric resection

4. Therapy with recombinant erythropoietin within the last 4 weeks

5. Chronic diarrhea

6. Chronic inflammatory bowel disease

7. Ferritin > 800 mg/dl at baseline

8. Hypersensitivity or contraindication to ferric carboxymaltose or iron (II) glycine sulphate complex

9. Known vitamin B12 or folic acid anemia

10. Necessary total parenteral nutrition

11. Participation in another interventional study

12. Pregnancy or lactation

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• FerInject
FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
• Ferro sanol
200 mg ferro sanol per day over 12 weeks

Locations

Country	Name	City	State
Germany	Klinikum Aschaffenburg	Aschaffenburg
Germany	Klinikum Bayreuth	Bayreuth
Germany	Augusta-Krankenanstalt gGmbH	Bochum
Germany	Medizinische Universitaetsklinik Bochum	Bochum
Germany	Krankenhaus Dresden-Friedrichstadt	Dresden
Germany	Universitätsklinikum Dresden	Dresden
Germany	Kliniken Essen Mitte	Essen
Germany	Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research	Frankfurt am Main	Hesse
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main
Germany	Universitätsklinik Halle-Wittenberg	Halle
Germany	Universitätskrankenhaus Eppendorf	Hamburg
Germany	NCT Heidelberg	Heidelberg
Germany	Gemeinschaftsklinikum Mittelrhein GmbH	Koblenz
Germany	Universitätsmedizin Mannheim	Mannheim
Germany	Klinikum Bogenhausen	Munich
Germany	Klinikum rechts der Isar	Munich
Germany	Elblandklinikum Riesa	Riesa
Germany	Caritas Klinikum St. Theresia	Saarbrucken

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rise or normalization of hemoglobin		12 weeks
Secondary	Fatigue as measured by EORTC-QLQ-FA13		12 weeks
Secondary	Quality of life as measured by EORTC-C30		12 weeks
Secondary	Handgrip strength as measured by Hydraulic Hand Dynamometer		12 weeks
Secondary	Number of allogenic blood transfusions (in total and per patient)		12 weeks
Secondary	Time until rise or normalisation of hemoglobin		12 weeks
Secondary	Genesis of the iron deficiency anemia		12 weeks
Secondary	Number of therapy with recombinant erythropoietin		12 weeks
Secondary	Dose of therapy with recombinant erythropoietin		12 weeks
Secondary	Duration of therapy with recombinant erythropoietin		12 weeks
Secondary	Inflammatory parameters		12 weeks
Secondary	Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002)		12 weeks
Secondary	Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002)		12 weeks
Secondary	Tolerance		12 weeks
Secondary	Incidence and severity of adverse events	incidence and severity of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) Version 4 criteria as assessed at day 1, 8, 15, 36, 50 and 64 and at end of treatment.	12 weeks
Secondary	Dropout rate due to toxicity or patient will		12 weeks
Secondary	Overall survival		12 weeks

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