DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

Information source: Johannes Gutenberg University Mainz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer Metastatic

Intervention: FOLFIRI + Cetuximab (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Dr. Carl Schimanski

Official(s) and/or principal investigator(s):
Carl Christoph Schimanski, PD Dr. med., Principal Investigator, Affiliation: Universitätsmedizin Mainz

Summary

The purpose of this interventional study is to assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal prophylaxis. Further Objectives: 1. Development of acneiforme follicular exanthema >= grade 2 2. Duration until development of acneiforme follicular exanthema >= grade 2 3. Development of paronychia 4. Development skin fissure (hand and foot) 5. Objective remission according RECIST 1. 1 6. Rate of secondary resections of liver metastasis with a curative approach 7. Assessment of safety and tolerability 8. Overall survival 9. Progression free survival

Clinical Details

Official title: Non-randomized Phase-IV-study to Investigate the Efficacy of FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

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

Primary outcome: Progression-free survival

Secondary outcome:

Progression-free survival

ORR

OS

Duration until development of acneiforme follicular exanthema >= grade 2

Development of paronychia

Development of skin fissure (hand and foot)

Rate of secondary resections of metastasis of liver with a curative approach

Assessment of safety and tolerability

Development of acneiforme follicular exanthema >= grade2

Detailed description: Subjects with metastatic colorectal cancer and confirmed KRAS-wildtype status in 1st line therapy will be included in this phase IV-study. Subject will receive a regimen of FOLFIRI in combination with Cetuximab every two weeks during study treatment phase. Treatment continues until

- disease progression

- complete response

- development of status of operability

- an uncontrollable exanthema grade 3 or 4 or

- intolerable toxicity is diagnosed. After study discontinuation or end of treatment,

respectively, patients will be followed up until the the last patient was treated for 12 months and has completed the 36-months follow up phase. Tumor response will be evaluated (according to RECIST 1. 1) every 12 weeks and at the end of study treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically-confirmed metastatic colorectal cancer (primary tumor or metastasis)

- Confirmation of KRAS wildtype status

- Confirmation of EGFR-Expression in the tumor

- Stadium IV

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Qualified for an application of FOLFIRI + Cetuximab treatment

- Signed patient informed consent form

- Of either gender and aged 18 years or more

- Estimated lifespan more than 3 months

- Measurable disease according to RECIST 1. 1 guidelines. The evaluation has to be max.

4 weeks

- Effective and adequate contraceptive precautions of man or woman in a childbearing

potential age (double barrier method)

- Leucocytes ≥ 3,0 x 10^9/L with neutrophils ≥ 1,5 x 10^9/L, thrombocytes ≥ 100 x

10^9/L, haemoglobin ≥ 5,6 mmol/L

- Serum bilirubin ≤ 1,5 x ULN (upper limit of normal)

- ALAT and ASAT ≤ 2,5 x ULN; if metastasis in liver, than ALAT and ASAT ≤ 5 x ULN

- Serum creatinin ≤ 1,5 x ULN

- If applicable a prior operation has to be min. 4 weeks ago, biopsy more than 1 week

until initiation of treatment. Wounds of operations had to be completely cured

- No toxicity of prior treatments

Exclusion Criteria:

- KRAS-gene mutation

- Confirmation of non-EGFR-Expression

- Prior treatment with an EGRF-receptor inhibitor

- Prior chemotherapy of the mCRC, except (neo-)adjuvant therapy, which had to be ended

min. 6 months before recruitment

- Experimental treatment medication within 30 days before recruitment

- Known hypersensitivity against components of the chemotherapy, cetuximab,

doxycycline, Reconval K1 or Dermatop

- Rosacea

- Other chronic dermal diseases with development of papula or pustule

- Known lung fibrosis or interstitial pneumonitis or interstitial lung diseases

- keratitis, ulcerative keratitis or severe form of dry eye

- Pregnancy or breast feeding

- Brain metastasis

- Clinical relevant coronary heart disease, myocardial infarction within the last 12

months or high risk of uncontrollable arrhythmia

- Acute or subacute ileus or chronic colon-inflammation or chronic diarrhea

- Symptomatic peritoneal carcinomatosis

- Serious, non-healing wounds, ulcera or bone fractures

- Uncontrollable arterial hypertension

- Therapeutic anticoagulation (e. g. therapy with marcumar)

- Known dihydropyrimidine dehydrogenase deficiency

- Gilbert-Meulengracht-syndrome

- Other malignant tumours less than five years old. Exceptions include basocellular

carcinoma or an in situ cancer of the cervix uteri if they are curative treated as well as an untreated, locally confined, asymptotic "low risk" (indolent) prostata carcinoma (Stage T ≤ T1-2a, PSA < 15 ng/ml, Gleason-Score ≤ 6 ).

- Known abuse of narcotic drugs or alcohol

- Any kind of disorder that compromises the ability of the subject to give written

informed consent and/or comply with the study procedures

- Any significant concomitant disease that excludes the participation to the study

- Missing or limited juristic contractual capability

Locations and Contacts

Universitätsmedizin Mainz, Mainz 55131, Germany
Additional Information

Starting date: January 2011
Last updated: December 17, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017