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Metastatic Colorectal CancersPhase 1MOMENTUM1NCT01843725

Phase 1 Study Testing the Combination of Aflibercept and Capecitabine in Metastatic Digestive and Breast Cancers

A Phase 1 study testing capecitabine and aflibercept in people with Metastatic Colorectal Cancers and Metastatic Gastric Cancers, run by Jules Bordet Institute at 1 site in Belgium.

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

Prospective non randomized, non-comparative, dose escalation, two arms open phase I trial to assess the safety and tolerability of capecitabine given in combination with aflibercept in patients with measurable or evaluable, chemorefractory digestive tumors or breast tumors in terms of the Maximum Tolerated Dose (MTD)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
capecitabine and aflibercept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteBelgium
Study dates
Sep 2013to Oct 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

Who may be able to join

  • Histologically confirmed digestive or breast cancer that is metastatic or unresectable, for which no curative measures are possible, and chemorefractory to all known medications in the respective fields.
  • Age ≥ 18 years.
  • Life expectancy of greater than 12 weeks.
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1.
  • Normal organ and marrow function as defined below:
  • Leukocytes > 3,000/microLiter (mcL)
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  • Hb>10g/mcL
  • Absolute neutrophil count > 1,500/mcL
  • Platelets > 100,000/mcL
  • Total bilirubin within 2 × institutional upper limit of normal
  • AST (aspartate amino transferase)/ALT (alanine amino transferase)/ALKP (Alkaline Phosphatase) levels < 5 × institutional upper limit of normal for liver metastases, < 2.5 ULN (Upper Limit of Normal) in case of no liver metastases
  • Creatinine within 2 × institutional upper limit of normal or creatinine clearance > 35 mL/min
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Signed written informed consent (approved by an Independent Ethics Committee (IEC)) obtained prior to any study specific baseline procedures.

Who cannot join

  • Patients with malabsorption or dysfunctional GI tract.
  • Participants who have had chemotherapy or radiotherapy (except limited radiotherapy for bone metastasis for instance) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Participants should not receive any other experimental agents.
  • Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of cardiovascular ischemic disease or cerebrovascular incident within the last six months, NYHA class III and IV congestive heart failure.
  • Intolerance to atropine sulfate or loperamide
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  • Known dihydropyrimidine dehydrogenase deficiency
  • Treatment with CYP3A4 inducers unless discontinued > 7 days prior to randomization
  • Any of the following in 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis.
  • Major surgery within 6 weeks.
  • Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence).

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Institut Jules Bordet

    Brussels, 1000

Other trials in Belgium

About this study

Official title: Modulation of Metabolic Index in Tailoring Treatment of Incurable Metastatic ColoRectal Cancer (CRC) Program 1.

Prospective non randomized, non-comparative, dose escalation, two arms open phase I trial to assess the safety and tolerability of capecitabine given in combination with aflibercept in patients with measurable or evaluable, chemorefractory digestive tumors or breast tumors in terms of the Maximum Tolerated Dose (MTD) and the Dose-Limiting Toxicities (DLTs), To establish the Recommended Phase II Dose (RP2D) of capecitabine in combination with Aflibercept.

Read the detailed description

Aflibercept has been found to be active with a broad pharmacological index against early and advanced stage disease in a variety of preclinical solid tumor models including sarcomas, and ovarian, prostate, mammary, colon, and gastric carcinomas either as a single agent or in combination with cytotoxic agents.

Metronomic chemotherapy, namely administration of continuous low-dose chemotherapy at close, regular intervals, with no prolonged drug-free interruptions, bases its rationale on the fact that virtually all classes of cancer chemotherapeutic drugs are designed to damage DNA or disrupt microtubules of dividing cells. Endothelial cell division takes place during new blood vessel formation, including tumour angiogenesis. Frequent administration of most cytotoxic agents at low doses is thought to increase their putative antiangiogenic activity.

This strategy lowers the toxicity and theoretically the risk of emergence of drug-resistant tumour cells compared to classic maximum tolerated dose (MTD)-based chemotherapy.

Being tested
capecitabine, aflibercept
Keywords
breast cancer, digestive cancer
Medical subject headings
Colorectal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Biliary Tract Neoplasms, Breast Neoplasms, Gastrointestinal Neoplasms

What participants receive

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

  • capecitabineDrug

    Also called Xeloda

    escalation dose of capecitabine continuously

  • afliberceptDrug

    Also called Zaltrap

    Intravenous 6mg/kg every 3 weeks

  • CapecitabineDrug

    Also called Xeloda

    dose escalation, from 1700 to 2500mg/m2/day 2 weeks out of 3

Study groups in NCT01843725
Study groupRoleWhat they receive
Metronomic armExperimentalcapecitabine 1100 to 1600 mg/m2/day orally in association with aflibercept 6mg/kg intravenous every 3 weeks
Receives: Drug: capecitabine; Drug: aflibercept
Intermittent armExperimentalcapecitabine 1700 to 2500 mg/m2/day orally 2 weeks out of 3 and aflibercept 6mg/kg intravenous every 3 weeks
Receives: Drug: aflibercept; Drug: Capecitabine

What is being measured

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

  1. To determine the maximum tolerated dose and the recommended phase II dose of capecitabine in association with aflibercept

    To assess the safety and tolerability of capecitabine given in combination with aflibercept in patients with measurable or evaluable, chemorefractory digestive tumors or breast tumors in terms of the Maximum Tolerated Dose (MTD), the Dose-Limiting Toxicities (DLTs), and to determine the Recommended Phase II Dose (RP2D) of capecitabine in combination with aflibercept.

    Measured: The time point of the first toxicity evaluation would be the end of the first cycle (3 weeks)

Secondary outcomes (1)

  1. The secondary endpoint is preliminary data on efficacy, and this will be evaluated using CT scan or MRI using RECIST (Response Evaluation Criteria in Solid Tumors) v1.1

    Measured: after 2 cycles (6 weeks)

Timeline

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

  1. First posted1 May 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionOct 2016
  4. Study completionOct 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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01843725
Sponsor's protocol ID
Mom1-AD12
Other IDs
2012-005169-11
Acronym
MOMENTUM1
Status last verified
Aug 2017
First submitted
25 Apr 2013
Last updated
31 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Camera S, Deleporte A, Bregni G, Trevisi E, Pretta A, Telli TA, Polastro L, Gombos A, Kayumba A, Ameye L, Piccart-Gebhart M, Awada A, Sclafani F, Hendlisz A. MOMENTUM: A Phase I Trial Investigating 2 Schedules of Capecitabine With Aflibercept in Patients With Gastrointestinal and Breast Cancer. Clin Colorectal Cancer. 2020 Dec;19(4):311-318.e1. doi: 10.1016/j.clcc.2020.05.007. Epub 2020 May 29.

    PubMed 32631787

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing capecitabine and aflibercept in people with Metastatic Colorectal Cancers and Metastatic Gastric Cancers, run by Jules Bordet Institute at 1 site in Belgium.

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 14 inclusion and 12 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: finished, as of the sponsor's last update on 31 Jan 2018. 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 Belgium. 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?

To determine the maximum tolerated dose and the recommended phase II dose of capecitabine in association with aflibercept (time frame: The time point of the first toxicity evaluation would be the end of the first cycle (3 weeks)). 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 NCT01843725, 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 31 Jan 2018.

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