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Colorectal AdenocarcinomaPhase 3NCT03300609

5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab

A Phase 3 study testing Panitumumab, Oxaliplatin and Leucovorin Calcium in people with Colorectal Adenocarcinoma and RAS Wild Type, run by University of Southern California at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized trial studies how well panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction work in treating patients with RAS wild type colorectal cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body or cannot be… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Panitumumab, Oxaliplatin and Leucovorin Calcium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
27 Feb 2018to 3 Oct 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic or locally advanced (unresectable) colorectal cancer with histological confirmation of adenocarcinoma (patients with or without measurable disease by imaging are eligible)
  • No prior systemic chemotherapy for metastatic disease; subjects who received adjuvant therapy with FOLFOX and at the time of recurrence are at least 6 months away from last chemotherapy are eligible for this study
  • At the time of randomization to maintenance therapy only patients who didn't progress by Response Evaluation Criteria in Solid Tumors (RECIST) criteria are eligible; patients with complete response (CR) and those who are candidates for resection will not be eligible for randomization to maintenance therapy, subjects who undergo surgery potentially have curable disease with defined duration of treatment and use of EGFR in the adjuvant setting is deemed to be detrimental in these population; likelihood of achieving CR is low and standard of care in this unique patient population is not well defined
  • Provide written informed consent
  • RAS wild-type tumor
  • Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
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  • Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 or 1
  • Total serum bilirubin =< institutional upper limit of normal (ULN)
  • Absolute neutrophil count (ANC) >= 1500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 9.0 g/dL (hemoglobin may be supported by transfusion)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)
  • Creatinine within institutional limits of normal OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Magnesium >= lower limit of normal
  • Willing to provide tissue and blood samples for mandatory correlative and research purposes

Who cannot join

  • Patients who are candidates for upfront metastasectomy (defined as those with limited liver metastatic disease) are not eligible for this study; the candidacy for resectability can be determined by the treating physician and or local surgeon; in ambiguous situations, please discuss the case with the principle investigator (PI)
  • Known or suspected brain or central nervous system (CNS) metastases
  • Active, uncontrolled infection, including hepatitis B, hepatitis C
  • Patients with history of interstitial lung disease/pulmonary fibrosis
  • Concurrent anti-cancer therapy, including chemotherapy agents, targeted agents, or biological agents not otherwise specified in this protocol
  • Radiation therapy =< 2 weeks prior to randomization
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  • Any of the following
  • Pregnant or nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease, history of any psychiatric or addictive disorder, or laboratory abnormality, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Patients known to be human immunodeficiency virus (HIV) positive
  • Uncontrolled intercurrent illness whom in the opinion of the investigator, may increase the risks associated with study participation or study treatment, or may interfere with the conduct of the study or the interpretation of the study results
  • Receiving any other investigational agent, which would be considered as a treatment for the primary neoplasm
  • Other active malignancy =< 3 years prior to registration; exceptions are: nonmelanoma skin cancer or carcinoma-in-situ of the cervix that has been treated
  • History of prior malignancy for which patient is receiving other specific treatment for their cancer
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: Randomized Phase III Trial of 5-FU Based Maintenance Therapy With or Without Panitumumab in Patients With RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX + Panitumumab

This randomized trial studies how well panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction work in treating patients with RAS wild type colorectal cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction may work better in treating patients with colorectal cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the duration of progression free survival 1 (PFS1) in patients with RAS wild type who have received induction leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) + panitumumab and not progressed at 6 cycles and randomized to maintenance therapy with fluorouracil (5FU) based therapy with or without panitumumab.

SECONDARY OBJECTIVES:

  1. To compare the response rate (RR) in patients with RAS wild type who are randomized to maintenance therapy with 5FU based therapy to those randomized to 5FU based therapy with panitumumab.

TERTIARY OBJECTIVES:

  1. Progress free survival 2 (PFS2). II. To assess the adverse event (AE) profile and safety of the proposed treatment in this population.

III. To assess and compare the overall survival (OS) between the two treatment groups.

IV. To compare the quality of life (QOL) as measured by health state index (HIS) between patients who achieve partial response (PR) versus (vs.) those who progress and those who have stable disease during the induction phase.

  1. To compare the QOL as measured by HSI between the two groups randomized to maintenance therapy.

VI. To assess the evolution of RAS mutation under treatment during induction phase as well as maintenance.

VII. To explore relationship between genomic and proteomic alterations of the tumor with response and PFS to panitumumab.

OUTLINE:

INDUCTION:

Patients receive panitumumab intravenously (IV) over 30-60 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil over 46-48 hours on day 1. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients who are not candidates for surgery, have no disease progression, or do not have complete response after Induction are randomized to 1 of 2 arms.

ARM I: Patients receive panitumumab IV over 30 minutes, leucovorin calcium IV, and fluorouracil over 46-48 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive capecitabine orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PanitumumabBiological

    Also called 339177-26-3, ABX-EGF, ABX-EGF Monoclonal Antibody, Clone E7.6.3

    Given IV

  • OxaliplatinDrug

    Also called 1-OHP, 266046, 61825-94-3, Aiheng

    Given IV

  • Leucovorin CalciumDrug

    Also called 1492-18-8, 5-Formyl Tetrahydrofolate, 5-Formyl-5,6,7,8-tetrahydrofolic Acid, 5-Formyl-5,6,7,8-tetrahydropteroyl-L-glutamic Acid

    Given IV

  • FluorouracilDrug

    Also called 19893, 2,4-Dioxo-5-fluoropyrimidine, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluoro-2,4(1H,3H)-pyrimidinedione

    Given IV

  • CapecitabineDrug

    Also called 154361-50-9, 5'-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-cytidine, 712807, Ro 09-1978/000

    Given PO

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT03300609
Study groupRoleWhat they receive
Arm I (panitumumab, leucovorin calcium, fluorouracil)ExperimentalINDUCTION Patients receive panitumumab IV over 30-60 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil over 46-48 hours on day 1. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive panitumumab IV over 30 minutes, leucovorin calcium IV, and fluorouracil over 46-48 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Panitumumab; Drug: Oxaliplatin; Drug: Leucovorin Calcium; Drug: Fluorouracil; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis
Arm II (capecitabine)Active comparatorINDUCTION Patients receive panitumumab IV over 30-60 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil over 46-48 hours on day 1. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive capecitabine PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Panitumumab; Drug: Oxaliplatin; Drug: Leucovorin Calcium; Drug: Fluorouracil; Drug: Capecitabine; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival 1

    Disease progression will be determined by comparing tumor measurement during maintenance therapy to baseline measurement before starting maintenance treatment using Response Evaluation Criteria in Solid Tumors 1.1. will be conducted based on the intent-to-treat population from the time of randomization.

    Measured: From the date of randomization to the date of 1st documented disease progression or death due to any cause, whichever occurs first, assessed up to 7 months.

Secondary outcomes (1)

  1. Treatment Response

    Response will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1)

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2017
  2. Study start27 Feb 2018
  3. Primary completion3 Oct 2019
  4. Study completion3 Oct 2019

Why it stopped: Insufficient Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03300609
Sponsor's protocol ID
3C-16-6
Other IDs
NCI-2017-01414, 3C-16-6, P30CA014089
Status last verified
Jun 2020
First submitted
28 Sep 2017
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Panitumumab, Oxaliplatin and Leucovorin Calcium in people with Colorectal Adenocarcinoma and RAS Wild Type, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival 1 (time frame: From the date of randomization to the date of 1st documented disease progression or death due to any cause, whichever occurs first, assessed up to 7 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03300609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020; AzTrials last refreshed its copy on 30 Oct 2026.

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