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Second-line FOLFIRI + Panitumumab in Subjects With Wild Type RAS Metastatic Colorectal

NCT03751176 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-06-30

No results posted yet for this study

Summary

To estimate progression-free-survival at 6 months in subjects treated in first-line with panitumumab and FOLFOX and with wild type RAS mCRC (metastatic colorectal cancer) confirmed in liquid biopsies before starting second line treatment will be screened for this trial and who have interrupted panitumumab for \<3 months (panitumumab continuation). Control arm of subjects treated with FOLFIRI alone will be included.

The combinations of 5-fluorouracil (5-FU) with oxaliplatin (FOLFOX)are considered the backbone chemotherapy for mCRC. Clinical trials have shown the benefit of adding monoclonal antibodies to subjects without mutations in RAS, directed against the epidermal growth factor receptor (EGFR) (cetuximab and panitumumab) to conventional chemotherapy as first-line treatment of mCRC. This trial purposes to study the treatment beyond progression with panitumumab in subjects treated in first-line with an anti-EGFR monoclonal antibody, or rather,the re-introduction of the same targeted therapy after progression to first line.

The clinical hypothesis of this study is that the second-line regimen FOLFIRI + panitumumab, is sufficiently active (defined as a 6-months PFS higher than 30% \[based on prior results with second-line FOLFIRI alone\] and of at least 50%), justifying further study in this population.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

Panitumumab

Panitumumab 6 mg/kg will be administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy

DRUG

Irinotecan

Irinotecan 180 mg/m2 will be administered as IV infusion over 90 min on day 1

DRUG

Folinic acid

Folinic acid 200-400 mg/m2 will be administered as IV infusion over 2 hours on day 1

DRUG

5-FU

5-FU will be administered IV 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Pivotal S.L.

    collaborator INDUSTRY

  • Grupo Espanol Multidisciplinario del Cancer Digestivo

    lead OTHER

Principal Investigators

  • Jorge Aparicio, MD · Hospital universitari i Politecnic La Fe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2020-11-30
Completion
2022-11-30

Countries

  • Spain

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03751176 on ClinicalTrials.gov