Hepatic Arterial Chemotherapy With Raltitrexed and Oxaliplatin Versus Standard Chemotherapy in Unresectable Liver Metastases From Colorectal Cancer After Conventional Chemotherapy Failure

NCT01348412

Last updated date
Study Location
Centre Georges François Leclerc
Dijon, , 21000, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Cancer, Liver Metastases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Informed consent signature by the patient-

- Cover by an health insurance

- Age between 18 and 75 years

- Age between 76 et 80 years if patient WHO Status 0

- WHO status of 0 or 1

- Estimated Life expectancy > 3 months

- Hepatic metastases of colorectal cancer confirmed on CT Scan without extra-hepatic metastasis (the presence of asymptomatic primary tumor is tolerated)

- TEP-Scan without fixation outside the liver and the primary tumor

- Histological proven colorectal cancer obtained from primary tumor or the hepatic metastases

- Metastases not accessible to curative hepatectomy (impossible R0 surgery or leaving less than 30 % of residual liver), or requiring a complex, very wide hepatectomy (5 segments or more) and\or risky procedure (RPC Class II)- - Presence of hepatic lesion > 10 mm on CTScan or hepatic MRI

- Failure or arrest of a previous chemotherapy because of intolerance to oxaliplatin, irinotecan, a fluoropyrimidine and/or target therapies (bevacizumab, cetuximab or panitumumab given for tumor expressing wild type Ki-Ras)

- Bilirubinemia< 1,5 times the superior limit of the normal ( N ),

- ASAT and ALAT < 5 N,

- Creatinemia < 1.5 N and creatinine clearance > 65ml/mn,

- Neutrophils > 1,5 x 109/L, platelets 100 x 109/L, hemoglobin > 9 g/dL (patients includables even after red blood cell transfusion)-Reference CTScan +/-MRI performed in 21 days preceding the first cycle of treatment

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- extra-hepatic metastases (presence of 1 to 3 pulmonary nodules, of a maximal diameter
of 5 mm with non specific aspect on CTScan and with no fixation on TEP Scan does not
constitute a criterion of exclusion)


- Symptomatic primary colorectal tumor in place


- Contraindication for allergy of rank 3-4 for one of the compounds of chemotherapy-
Peripheral neuropathy > 2 (Levy Scale)


- Current participation or in the 30 days preceding the inclusion in the study in
another therapeutic trial with an experimental molecule


- Concomitant systemic treatment by immunotherapy, chemotherapy or hormonotherapy-
Unbalanced serious illness, unchecked active infection or the other underlying serious
disorder susceptible to prevent the patient from receiving the treatment


- Pregnancy (pregnancy test compulsory for the inclusion), breast-feeding


- Intestinal occlusion or sub-occlusion or history of inflammatory intestinal disease


- Other cancer during the 5 years preceding entry in the trial or concomitant (except in
situ cancer of the cervix or skin basal cell carcinoma)Patient in custody or under
guardianship, Impossibility to adhere to the medical follow-up for geographical,
social or psychiatric reason

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Advanced Information
Descriptive Information
Brief Title  ICMJE Hepatic Arterial Chemotherapy With Raltitrexed and Oxaliplatin Versus Standard Chemotherapy in Unresectable Liver Metastases From Colorectal Cancer After Conventional Chemotherapy Failure
Official Title  ICMJE Phase II Randomized Study Comparing the Association of Intraarterial Perfusion of Raltitrexed and Oxaliplatin Versus Standard Chemotherapy Using Intravenous Perfusion for Colorectal Cancer Patient With Metastases Localized to Liver After Failure of Conventional Treatments.
Brief Summary Standard treatment of metastatic colorectal cancers relies on fluoropyrimidines, irinotecan alone or in association with fluoropyrimidines, oxaliplatin in association with fluoropyrimidines, bevacizumab and anti EGFR antibodies. After failure of classical regimen the national reference frame on the basis of phase II study proposes an association of fluoropyrimidine and mitomycin. These treatments give response rates of 10-20% with progression free survivals from 2 to 3 months. Hepatic intra-arterial chemotherapy is logical in the case of isolated hepatic metastases nonaccessible to curative resection: 1) hepatic metastases are vascularized by hepatic arterial system in contrast to nontumoral hepatic parenchyma; 2) arterial perfusion of oxaliplatin leads to a strong extraction by the liver during the first passage, a high intra-tumoral concentration and a low systemic concentration. So oxaliplatin is a drug of choice for arterial treatment but combination with fluoropyrimidines is impossible because of need for prolonged perfusion. Floxuridin is not available in France. Raltitrexed, a definitive inhibitor of the thymidylate synthase, does not require a prolonged perfusion and could be a good substitute.In a previous pilot study we demonstrated the feasibility, safety and efficacy of combination of raltitrexed and oxaliplatin arterial perfusion. Now we propose a phase II randomized clinical trial to evaluate the efficacy of hepatic arterial infusion of raltitrexed and oxaliplatin association versus standard chemotherapy for patients with metastases of colorectal origin restricted to the liver after failure of conventional chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Liver Metastases
Intervention  ICMJE
  • Drug: oxaliplatin
    130 mg/m²Every 21 days
  • Drug: raltitrexed
    3 mg/m² with a maximum of 6 mg every 21 days
  • Drug: other intravenous chemotherapy drugs
Study Arms  ICMJE
  • Experimental: ARM A
    Hepatic artery infusion through an implanted arterial catheter of the combination of raltitrexed (3 mg/m ²) and oxaliplatin (100 mg/m ²) every 21 days.
    Interventions:
    • Drug: oxaliplatin
    • Drug: raltitrexed
  • Active Comparator: ARM B
    Intravenous standard chemotherapy.
    Intervention: Drug: other intravenous chemotherapy drugs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2018)
31
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2011)
80
Actual Study Completion Date  ICMJE April 18, 2018
Actual Primary Completion Date December 15, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent signature by the patient-
  • Cover by an health insurance
  • Age between 18 and 75 years
  • Age between 76 et 80 years if patient WHO Status 0
  • WHO status of 0 or 1
  • Estimated Life expectancy > 3 months
  • Hepatic metastases of colorectal cancer confirmed on CT Scan without extra-hepatic metastasis (the presence of asymptomatic primary tumor is tolerated)
  • TEP-Scan without fixation outside the liver and the primary tumor
  • Histological proven colorectal cancer obtained from primary tumor or the hepatic metastases
  • Metastases not accessible to curative hepatectomy (impossible R0 surgery or leaving less than 30 % of residual liver), or requiring a complex, very wide hepatectomy (5 segments or more) and\or risky procedure (RPC Class II)- - Presence of hepatic lesion > 10 mm on CTScan or hepatic MRI
  • Failure or arrest of a previous chemotherapy because of intolerance to oxaliplatin, irinotecan, a fluoropyrimidine and/or target therapies (bevacizumab, cetuximab or panitumumab given for tumor expressing wild type Ki-Ras)
  • Bilirubinemia< 1,5 times the superior limit of the normal ( N ),
  • ASAT and ALAT < 5 N,
  • Creatinemia < 1.5 N and creatinine clearance > 65ml/mn,
  • Neutrophils > 1,5 x 109/L, platelets 100 x 109/L, hemoglobin > 9 g/dL (patients includables even after red blood cell transfusion)-Reference CTScan +/-MRI performed in 21 days preceding the first cycle of treatment

Exclusion Criteria:

  • extra-hepatic metastases (presence of 1 to 3 pulmonary nodules, of a maximal diameter of 5 mm with non specific aspect on CTScan and with no fixation on TEP Scan does not constitute a criterion of exclusion)
  • Symptomatic primary colorectal tumor in place
  • Contraindication for allergy of rank 3-4 for one of the compounds of chemotherapy- Peripheral neuropathy > 2 (Levy Scale)
  • Current participation or in the 30 days preceding the inclusion in the study in another therapeutic trial with an experimental molecule
  • Concomitant systemic treatment by immunotherapy, chemotherapy or hormonotherapy- Unbalanced serious illness, unchecked active infection or the other underlying serious disorder susceptible to prevent the patient from receiving the treatment
  • Pregnancy (pregnancy test compulsory for the inclusion), breast-feeding
  • Intestinal occlusion or sub-occlusion or history of inflammatory intestinal disease
  • Other cancer during the 5 years preceding entry in the trial or concomitant (except in situ cancer of the cervix or skin basal cell carcinoma)Patient in custody or under guardianship, Impossibility to adhere to the medical follow-up for geographical, social or psychiatric reason
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01348412
Other Study ID Numbers  ICMJE 0329-1ghfr09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Georges Francois Leclerc
Study Sponsor  ICMJE Centre Georges Francois Leclerc
Collaborators  ICMJE
  • National Cancer Institute, France
  • Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE Not Provided
PRS Account Centre Georges Francois Leclerc
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP