AzTrials
AzTrials

Colorectal Cancer MetastaticPhase 2Drop and GoNCT02085005

Capecitabine Plus Aflibercept as Maintenance Therapy Following Capecitabine Plus Oxaliplatin Plus Aflibercept in Patients With Metastatic Colorectal Cancer

A Phase 2 study testing Capecitabine, Aflibercept AVE0005 and Oxaliplatin SR96669 in people with Colorectal Cancer Metastatic, run by Sanofi.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Primary Objective: Efficacy: To assess the progression-free survival rate at 10 months in patients on maintenance therapy with capecitabine plus aflibercept. Secondary Objectives: To evaluate: Efficacy: Progression Free Survival (PFS) Efficacy: Overall Survival (OS) Efficacy: Objective Response Rate (ORR) as per… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Capecitabine, Aflibercept AVE0005 and Oxaliplatin SR96669
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2014to Aug 2016
Phase
Phase 2
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

  • Age ≥18 years of both sexes
  • Histologically confirmed mCRC
  • Unresectable metastatic colorectal cancer. (Patient with resectable metastases (liver or lung) is not eligible.)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • A life expectancy of >3 months
  • At least one measurable lesion according to RECIST (version 1.1)
Show all 13Show fewer
  • No prior chemotherapy for advanced disease. Patients with prior (neo)adjuvant chemotherapy completed more than 6 months prior metastatic relapse are eligible (adjuvant does not include the chemotherapy after resection of distant metastases).
  • Adequate hematological profile (absolute neutrophil count >1.5 x 109/L, platelet count >100 x 109/L, hemoglobin >9 g/dL)
  • Adequate liver function: AST, ALT <3.0 x ULN (or <5 xULN in the case of liver function abnormalities due to underlying liver metastases); Alkaline Phosphatase <3 x ULN (or <5 x ULN if due to underlying liver metastases); Total bilirubin <1.5 x ULN
  • Serum creatinine < 1.5 x upper limit of normal (ULN). If creatinine 1.0-1.5 x ULN, creatinine clearance will be calculated according to the CKD-EPI formula and creatinine clearance < 60 mL/min will exclude the patient
  • Proteinuria <2+ functions
  • Signed patient informed consent before beginning specific protocol procedures
  • Ability to comply with protocol requirements

Who cannot join

  • Less than 4 weeks from prior radiotherapy to the time of inclusion (less than 2 weeks in case of palliative RT on single bone lesion only)
  • Less than 4 weeks following major surgery to the time of inclusion or until the surgical wound is fully healed whichever came later (48 hours in case of minor surgical procedure or until wound full healing observed)
  • Treatment with any other investigational product within 28 days prior to inclusion
  • Other prior neoplasm. Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the patient has been disease-free for > 5 years are allowed
  • History of brain metastases (unless adequately controlled, i.e. previously irradiated, inactive brain metastases not requiring active treatment like steroids or antiepileptics), active seizure disorder, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
  • Any of the following within 6 months prior to inclusion: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack
Show all 22Show fewer
  • Any of the following within 3 months prior to inclusion: Grade 3-4 gastrointestinal bleeding/hemorrhage (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event
  • Occurrence of deep vein thrombosis within 4 weeks, prior to inclusion
  • Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results. Known Acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment
  • Pregnant or breast-feeding woman. Positive pregnancy test (serum or urine β-HCG) for women of reproductive potential
  • Patient with reproductive potential (M/F) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" will be based on the Investigator's judgment
  • Patient on anticoagulant therapy with warfarin (coumarin-derivative). Anticoagulation with low molecular weight heparin (LWMH) is permitted
  • Symptomatic peripheral sensory neuropathy grade ≥ 2 (NCI-CTCAE v4.03)
  • Inability to take oral medications
  • Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea, malabsorption syndrome, unresolved bowel obstruction/sub-obstruction, surgery more extensive than hemicolectomy, extensive small intestine resection with chronic diarrhea.
  • History of hypersensitivity to fluoropyrimidines or known/suspected allergy to any agent given during the study or to any excipient to study drugs
  • Known dihydropyrimidine dehydrogenase deficiency
  • Any contraindication to administer oxaliplatin, 5-FU, folinic acid or capecitabine as per package insert of each drug
  • Uncontrolled hypertension (defined as BP > 140/90 mmHg or systolic BP >160 mmHg when diastolic BP < 90 mmHg, on at least 2 repeated determinations on separate days, or upon clinical judgment) within 3 months prior to study inclusion
  • Evidence of clinically significant bleeding diathesis or underlying coagulopathy (e.g. INR>1.5 without vitamine K antagonist therapy), non-healing wound
  • History of hypersensitivity to Aflibercept (in case of prior administration for an indication other than cancer, i.e. ophthalmic indication)
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

About this study

Official title: Phase II Study of First-line Capecitabine Plus Oxaliplatin Plus Aflibercept for 6 Cycles Followed by Capecitabine Plus Aflibercept as Maintenance Therapy in Patients With Metastatic Colorectal Cancer: DROP and GO Trial

Primary Objective:

Efficacy: To assess the progression-free survival rate at 10 months in patients on maintenance therapy with capecitabine plus aflibercept.

Secondary Objectives:

To evaluate:

  • Efficacy: Progression Free Survival (PFS)
  • Efficacy: Overall Survival (OS)
  • Efficacy: Objective Response Rate (ORR) as per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria
  • Health related Quality of Life (HRQL): EORTC QLQ-C30 scores and EQ5D-3L
  • Safety

Exploratory Objective:

To collect blood and tumor samples to perform investigations for potential biomarker testing.

Read the detailed description

Total study duration for a participant can be up to 28 months.

This trial is being conducted in countries where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".

Being tested
Capecitabine, Aflibercept AVE0005, Oxaliplatin SR96669

What participants receive

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

  • CapecitabineDrug

    Pharmaceutical form:tablet Route of administration: oral

  • Aflibercept AVE0005Drug

    Pharmaceutical form:concentrate for infusion Route of administration: intravenous

  • Oxaliplatin SR96669Drug

    Pharmaceutical form:solution for infusion Route of administration: intravenous

Study groups in NCT02085005
Study groupRoleWhat they receive
AfliberceptExperimentalIntravenous (IV) infusion on Day 1 every 3 weeks, followed by CAPOX (capecitabine by oral administration on Day 1 to Day 14 and oxaliplatin intravenous (IV) infusion on Day 1 every 3 weeks) for the induction treatment period (6 cycles) after which the patient may enter the maintenance period during which the treatment is Aflibercept + Capecitabine
Receives: Drug: Capecitabine; Drug: Aflibercept AVE0005; Drug: Oxaliplatin SR96669

What is being measured

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

  1. Progression Free Survival rate at 10 months (PFS@10m)

    Measured: every 9 weeks, up to 28 months

Secondary outcomes (5)

  1. Progression Free Survival (PFS) - Time

    Measured: every 9 weeks, up to 28 months

  2. Overall Survival (OS) - Time

    Measured: every 9 weeks, up to 28 months

  3. Assessment of Objective Response Rate (ORR)

    Measured: every 9 weeks, up to 28 months

  4. Total Score as a measure of Health Related Quality of Life

    Measured: every 3 weeks, up to end of treatment

  5. Number of participants with adverse events

    Measured: up to 30 days after last treatment

Timeline

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

  1. First posted12 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionAug 2016 (estimated)
  4. Study completionAug 2016 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02085005
Sponsor's protocol ID
LPS13787
Other IDs
U1111-1149-0237
Acronym
Drop and Go
Status last verified
Nov 2014
First submitted
10 Mar 2014
Last updated
18 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Aflibercept AVE0005 and Oxaliplatin SR96669 in people with Colorectal Cancer Metastatic, run by Sanofi.

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 13 inclusion and 22 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: withdrawn, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 withdrawn before enrolling participants, so there are no results.

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 rate at 10 months (PFS@10m) (time frame: every 9 weeks, up to 28 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 NCT02085005.

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 18 Nov 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in