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Panitumumab-based Maintenance in Patients With RAS Wild-type, Metastatic Colorectal Cancer (Valentino) (Valentino)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02476045
Recruitment Status : Unknown
Verified September 2016 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : June 19, 2015
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:

Open label, randomized, multicenter, phase II study to compare the efficacy, in terms of non-inferiority of progression-free survival (PFS), of maintenance with panitumumab alone (arm B) as compared to panitumumab with 5-fluorouracil (5-FU) and leucovorin (LV) (arm A) following induction treatment with 5-fluorouracil + leucovorin+oxaliplatin (FOLFOX-4) and panitumumab in patients with RAS wild-type, metastatic colorectal cancer.

The study involves an induction phase with panitumumab as 1 hour intravenous infusion at the dosage of 6 mg/kg, given every two weeks, plus FOLFOX-4 chemotherapy as standard guidelines.

Before start of FOLFOX-4 plus panitumumab, at the time of enrollment, patients will be immediately randomized electronically 1:1 to one of the two maintenance arms. Induction treatment with FOLFOX-4 plus panitumumab will continue until progressive disease, unacceptable toxicity or informed consent withdrawal, or for up to 8 cycles. At the end of induction treatment, in presence of complete or partial response, or stable disease, non-progressing patients will be allocated to one of the two pre-assigned maintenance arms:

A) 5-FU/LV (De Gramont regimen) plus panitumumab given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or informed consent withdrawal B) Panitumumab alone given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or informed consent withdrawal Imaging studies (thorax and abdominal CT or MRI scan) will be performed at baseline (4 weeks prior enrollment) and every 8 weeks (4 cycles) during treatment.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: 5-fluorouracil,leucovorin,panitumumab Drug: panitumumab Drug: Oxaliplatin, 5-fluorouracil,leucovorin,panitumumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-line FOLFOX-4 Plus Panitumumab Followed by 5-FU/LV Plus Panitumumab or Single-agent Panitumumab as Maintenance Therapy in Patients With RAS Wild-type, Metastatic Colorectal Cancer: the VALENTINO Study
Study Start Date : June 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ARM A

Induction phase with panitumumab as 1 hour intravenous infusion at the dosage of 6 mg/kg, given every two weeks, plus FOLFOX-4 chemotherapy as standard guidelines.

Maintenance therapy with 5-FU/LV (De Gramont regimen) plus panitumumab given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or informed consent withdrawal

Drug: 5-fluorouracil,leucovorin,panitumumab
Maintenance treatment (ARM A)

Drug: Oxaliplatin, 5-fluorouracil,leucovorin,panitumumab
Induction treatment
Other Name: FOLFOX-4 + panitumumab

Experimental: ARM B

Induction phase with panitumumab as 1 hour intravenous infusion at the dosage of 6 mg/kg, given every two weeks, plus FOLFOX-4 chemotherapy as standard guidelines.

Maintenance therapy with panitumumab alone given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or informed consent withdrawal

Drug: panitumumab
Maintenance treatment (ARM B)

Drug: Oxaliplatin, 5-fluorouracil,leucovorin,panitumumab
Induction treatment
Other Name: FOLFOX-4 + panitumumab




Primary Outcome Measures :
  1. Efficacy [ Time Frame: 3 years ]
    in terms of progression free survival (from the enrollment)


Secondary Outcome Measures :
  1. Safety in terms of number of participants with adverse events. [ Time Frame: 3 years ]
    in terms of number of participants with adverse events.

  2. Quality of life [ Time Frame: 3 years ]
  3. Response rate [ Time Frame: 3 years ]
  4. duration of response [ Time Frame: 3 years ]
  5. time to progression [ Time Frame: 3 years ]
  6. time to treatment failure [ Time Frame: 3 years ]
  7. overall survival [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent prior to performance of any study procedure;
  2. Age ≥18 years;
  3. ECOG Performance Status 0-1;
  4. Life expectancy of at least 12 weeks in the opinion of the Investigator;
  5. Histologically or cytologically confirmed adenocarcinoma of the colon or rectum, with RAS wild-type status;
  6. Metastatic unresectable colorectal cancer not previously treated with standard chemotherapy for advanced or metastatic disease;
  7. Measurable or non-measurable metastatic lesion(s), as defined by RECIST version 1.1;
  8. Laboratory requirements:

    • Neutrophils >= 1.5 x 109/L, Platelets >= 100 x 109/L, and Haemoglobin >=10g/dL
    • Total bilirubin <= 1.5 time the upper-normal limits (UNL) of the Institutional normal values; ASAT (SGOT) and/or ALAT (SGPT) <= 2.5 x UNL, or <= 5 x UNL in case of liver metastases; alkaline phosphatase <= 2.5 x UNL, <= 5 x UNL in case of liver metastases, <= 10 x UNL in case of bone metastases; LDH <1500 U/L
    • Creatinine clearance (calculated according to Cockcroft and Gault) > 60 mL/min or serum creatinine <=1.5 x upper limit of normal (UNL);
  9. Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating center.
  10. Archival tumor tissue is required for exploratory research at enrolment.

Exclusion Criteria:

  1. Has a serious illness or medical condition(s) including, but not limited to the following:

    1. Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
    2. Known brain metastasis or leptomeningeal metastasis.
    3. Active infection (ie, body temperature ≥38°C due to infection).
    4. Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
    5. Intestinal obstruction, pulmonary fibrosis or interstitial pneumonitis, renal failure, liver failure, or cerebrovascular disorder.
    6. Uncontrolled diabetes.
    7. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
    8. Gastrointestinal hemorrhage.
    9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
    10. Autoimmune disorders or history of organ transplantation that require immunosuppressive therapy.
    11. Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
  2. Patients who had received adjuvant oxaliplatin-based chemotherapy and had recurrence during treatment or within 12 months from its completion are excluded. Patients who had received adjuvant fluoropyrimidine mono-therapy and had recurrence during treatment or within 6 months from its completion are excluded.
  3. Disease that is deemed potentially resectable after conversion chemotherapy is excluded. In particular, patients must be deemed unresectable by a multidisciplinary team, even when foreseeing a response to treatment. In case of liver metastases, the concept of resectability must take into account both the aim of oncological radicality (R0 resection) and remanent liver function considerations.
  4. Treatment with any of the following within the specified time frame prior to study drug administration:

    1. Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to study drug administration).
    2. Any anticancer therapy or investigational agent within prior 4 weeks
    3. Extended field radiation within prior 4 weeks or limited field radiation within prior 2 weeks.
  5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation). In particular, patients with platinum induced neurotoxicity greater than or equal CTCAE Grade 2 should be excluded.
  6. Is a pregnant or lactating female, or is planning to become pregnant during treatment and within 2 months after the end of treatment with panitumumab. Women of child-bearing potential with either positive or no pregnancy test at baseline. Women of child-bearing potential or sexually active men not willing to use contraception during study and for at least 2 months after end of treatment with panitumumab. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476045


Contacts
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Contact: Filippo Pietrantonio, MD 022390 ext 3807 filippo.pietrantonio@istitutotumori.mi.it
Contact: Monica Niger, MD 022390 ext 2844 monica.niger@istitutotumori.mi.it

Locations
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Italy
Fondazione IRCCS Istituto Nazionale dei tumori Recruiting
Milano, MI, Italy, 20133
Contact: Filippo Pietrantonio, MD    +39022390 ext 3807    filippo.pietrantonio@istitutotumori.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02476045    
Other Study ID Numbers: INT 70/15
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
metastatic colorectal cancer
RAS wild-type
maintenance therapy
panitumumab
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Fluorouracil
Panitumumab
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological