Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-09-30

Brief Summary

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The aim of this multicenter randomized phase II trial is to determine the efficacy of sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure of all active drugs known to be effective.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Irinotecan monotherapy

Intravenous infusion irinotecan 180 mg/m2 over 90 minutes (D1=D15) with cross over to irinotecan and sorafenib combination at progression.

Group Type ACTIVE_COMPARATOR

Irinotecan monotherapy

Intervention Type DRUG

Sorafenib monotherapy

Oral sorafenib 400 mg twice daily (total dose 800 mg/day) with cross over to irinotecan and sorafenib combination at progression

Group Type ACTIVE_COMPARATOR

Sorafenib monotherapy

Intervention Type DRUG

Sorafenib and irinotecan combination

Intravenous infusion irinotecan 120 mg/m2 over 90 minutes (D1=D15) at Cycle 1, 150 mg/m² at C2 if no diarrhea \> grade 1 and no other toxicity \> grade 2, and 180 mg/m² at C3 in the same conditions

* Oral sorafenib 400 mg twice daily (total dose 800 mg/day) from C1. 1 cycle = 15 days and 1 course = 4 weeks.

Group Type EXPERIMENTAL

Sorafenib and irinotecan combination

Intervention Type DRUG

Interventions

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Sorafenib and irinotecan combination

Intervention Type DRUG

Sorafenib monotherapy

Intervention Type DRUG

Irinotecan monotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥ 18 years old
* Histologically confirmed diagnosis of colorectal cancer
* Asymptomatic or resected primary tumor
* Metastatic colorectal cancer patient not eligible for curative surgery
* At least one target lesion:

* Unidimensionally measurable on cross-sectional imaging
* In an area not previously irradiated
* Disease progression after failure of active drugs (5-Fu or 5-Fu prodrugs, irinotecan, oxaliplatin, bevacizumab)
* Patients with bone metastases are eligible if they have other measurable lesions
* WHO performance status ≤ 2
* Confirmation of KRAS mutation in codons 12 or 13 in the primary tumor or metastases
* Total bilirubin ≤ 1.5 ULN, ALT or AST ≤ 2.5 ULN (or \< 5 in case of liver impairment)
* Haemoglobin ≥ 10 g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
* Serum creatinine ≤ 1.5 ULN
* Negative pregnancy test in women of childbearing potential
* Use of an effective contraceptive method during the whole treatment and up to 3 months after the completion of treatment in males and females
* Life expectancy of at least 3 months
* Informed consent signed prior any study specific procedures
* Tumor evaluation should be performed within 3 weeks prior to starting treatment

Exclusion Criteria

* History of Gilbert's syndrome
* Symptomatic brain metastases or carcinomatous meningitis
* Bone-only metastases
* History or presence of other cancers within the past 5 years (except curatively treated non-melanoma skin cancer and in situ cervical cancer)
* Prior surgery or radiotherapy within 4 weeks before entering the study
* Cardiac arrhythmia requiring treatment (except for beta-blockers and digoxin), unstable cardiac disease, myocardial infarction within the previous 6 months, \> grade II NYHA heart failure, uncontrolled hypertension
* Kalemia lower than normal serum potassium value
* From ECG, QTc interval \> 470 ms
* History of acute or chronic pancreatitis
* History of epileptic seizures requiring long-term anticonvulsant therapy
* History of organ transplantation with use of immunosuppression therapy
* Severe bacterial or fungal infection (Grade \> 2 NCI-CTCAE v.4.0)
* Known HIV infection
* Long-term use of CYP 3A4 enzyme-inducing agents such as rifampicin, St. John's Wort (hypericum perforatum), phenytoin, carbamazepine, phenobarbital, dexamethasone, and ketoconazole
* Pregnant or breastfeeding women
* Bowel malabsorption or extended bowel resection that could affect the absorption of sorafenib, occlusive syndrome, inability to take oral medications
* Inflammatory bowel disease with chronic diarrhea (NCI-CTCAE v.4.0)
* Participation in another clinical trial 30 days prior to study entry
* Concurrent treatment with any other investigational product or anticancer therapy (except for irinotecan or sorafenib)
* Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No