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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00610948

Everolimus, Fluorouracil, Leucovorin, Panitumumab, and Oxaliplatin in Treating Patients With Tumors That Did Not Respond to Treatment

A Phase 1 study testing panitumumab, everolimus and fluorouracil in people with Unspecified Adult Solid Tumor, Protocol Specific, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
panitumumab, everolimus and fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
Mar 2008to Jan 2016
Phase
Phase 1
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant solid tumor
  • Advanced or unresectable disease
  • No standard therapeutic option available
  • Evaluable disease (according to RECIST criteria) that has not been previously irradiated
  • Prior radiotherapy to the marker lesion(s) allowed provided there is evidence of progression since radiotherapy
  • Brain metastases allowed provided the following criteria are met:
  • CNS-directed treatment was given and was completed > 3 months ago
  • CNS disease has been clinically and radiographically stable for ≥ 8 weeks

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/µL
  • Platelet count ≥ 100,000/µL
  • Creatinine clearance ≥ 60 mL/min
  • Total bilirubin ≤ 1.2 mg/dL
  • Transaminases ≤ 5 times upper limit of normal (ULN)
  • Magnesium ≥ lower limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 24 weeks (females) or for 4 weeks (males) after completion of study therapy
  • Willing to avoid pregnancy for 3 months after completion of study therapy
  • No neuropathy ≥ grade 2
  • No concurrent life-threatening acute medical illness
  • No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • No active bleeding diathesis

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery, radiotherapy (including radiotherapy involving the abdomen or spine), chemotherapy, or other systemic anticancer therapy and recovered
  • At least 4 weeks since prior investigational drugs
  • No concurrent CYP3A4 inducers or inhibitors that cannot be substituted by a different agent
  • No concurrent oral anti-vitamin K medication (except for low-dose warfarin)
  • No concurrent colony stimulating factors during the first course of treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

Other trials in United States

About this study

Official title: A Sequential Phase I Study Of The Combination Of Everolimus (Rad001) With 5-Fu/Lv (De Gramont), Folfox6, And Folfox6/Panitumumab In Patients With Refractory Solid Malignancies

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving everolimus together with combination chemotherapy and/or panitumumab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with fluorouracil, leucovorin, panitumumab, and oxaliplatin in treating patients with solid tumors that did not respond to previous treatment.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of everolimus in combination with sequential fluorouracil (5-FU) and leucovorin calcium, panitumumab, modified 5-FU, leucovorin calcium, and oxaliplatin (mFOLFOX6), and mFOLFOX6 with panitumumab in patients with refractory solid tumors.

Secondary

  • To determine the adverse event profile of these regimens.
  • To correlate response with S6-phosphorylation and AKT-phosphorylation in available archived tumor samples.
  • To evaluate preliminary evidence of antitumor activity of these regimens using RECIST criteria for a subset of patients with measurable disease.

OUTLINE: This is a dose-escalation study. Cohorts of patients are enrolled into treatment groups 1 or 2. If a final cohort of patients is reached in groups 1 and/or 2, additional cohorts of patients are enrolled into treatment group 3.

  • Group 1: Patients receive oral everolimus once daily on days 1-28. Patients also receive leucovorin calcium IV followed by fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
  • Group 2: Patients receive oral everolimus once daily on days 1-28 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
  • Group 3: Patients receive oral everolimus once daily on days 1-28, leucovorin calcium IV followed by fluorouracil IV continuously over 46 hours beginning on day 1, and oxaliplatin IV over 2-4 hours on day 1. Some patients may also receive panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Archived tumor samples are assessed for phospho-AKT, phospho-S6K, and phospho-S6 by immunohistochemistry.

After completion of study treatment, patients are followed every 3 months for 1 year.

Keywords
unspecified adult solid tumor, protocol specific

What participants receive

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

Study groups in NCT00610948
Study groupRoleWhat they receive
Group 1ExperimentalPatients receive oral everolimus once daily on days 1-28. Patients also receive leucovorin calcium IV followed by fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: everolimus; Drug: fluorouracil; Drug: leucovorin calcium
Group 2ExperimentalPatients receive oral everolimus once daily on days 1-28 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: panitumumab; Drug: everolimus
Group 3ExperimentalPatients receive oral everolimus once daily on days 1-28, leucovorin calcium IV followed by fluorouracil IV continuously over 46 hours beginning on day 1, and oxaliplatin IV over 2-4 hours on day 1. Some patients may also receive panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: panitumumab; Drug: everolimus; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin

What is being measured

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

  1. Maximum tolerated dose of everolimus in combination with sequential fluorouracil (5-FU) and leucovorin calcium, panitumumab, modified 5-FU, leucovorin calcium, and oxaliplatin (mFOLFOX6), and mFOLFOX6 with panitumumab

    Patients will be assessed for toxicity at the commencement of each cycle

    Measured: after the first 28 day cycle

  2. Toxicity as assessed by CTC version 3.0 at the beginning of each treatment course

    Dose Limiting Toxicities (DLT) are defined during the first cycle (28 days).

    Measured: first 28 day cycle

  3. Tumor response

    Tumor response will be assessed by RECIST criteria

    Measured: Every 8 weeks during treatment

  4. Correlation of response with S6-phosphorylation and AKT-phosphorylation in archived tumor samples

    Measured: 3 years

Timeline

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

  1. First posted8 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMay 2013
  4. Study completionJan 2016

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00610948
Sponsor's protocol ID
LCCC 0621
Other IDs
P30CA016086, CDR0000584276
Status last verified
May 2017
First submitted
7 Feb 2008
Last updated
4 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • McRee AJ, Davies JM, Sanoff HG, Goldberg RM, Bernard S, Dees EC, Keller K, Ivanova A, O'Neil BH. A phase I trial of everolimus in combination with 5-FU/LV, mFOLFOX6 and mFOLFOX6 plus panitumumab in patients with refractory solid tumors. Cancer Chemother Pharmacol. 2014 Jul;74(1):117-23. doi: 10.1007/s00280-014-2474-0. Epub 2014 May 13.

    PubMed 24819684

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing panitumumab, everolimus and fluorouracil in people with Unspecified Adult Solid Tumor, Protocol Specific, run by UNC Lineberger Comprehensive Cancer Center 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?

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: finished, as of the sponsor's last update on 4 May 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose of everolimus in combination with sequential fluorouracil (5-FU) and leucovorin calcium, panitumumab, modified 5-FU, leucovorin calcium, and oxaliplatin (mFOLFOX6), and mFOLFOX6 with panitumumab (time frame: after the first 28 day cycle). The study lists 4 primary outcomes in all. 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 NCT00610948, which also lists 1 linked publication.

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 4 May 2017.

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