Know Cancer

or
forgot password

A Randomized Phase II Trial Assessing Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors After Failure of All Drugs Known to be Effective


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors

Thank you

Trial Information

A Randomized Phase II Trial Assessing Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors After Failure of All Drugs Known to be Effective


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Non-progression rate

Outcome Description:

To evaluate the non-progression rate at 2 months according to RECIST criteria (Version 1.1)

Outcome Time Frame:

At 2 months

Safety Issue:

No

Principal Investigator

Emmanuelle SAMALIN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CRLC Val d'Aurelle-Paul Lamarque

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

NEXIRI 2

NCT ID:

NCT01715441

Start Date:

September 2012

Completion Date:

September 2015

Related Keywords:

  • Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors
  • Metastatic colorectal cancer patients
  • KRAS mutation
  • Sorafenib
  • Colorectal Neoplasms

Name

Location