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Esophageal CarcinomaPhase 2NCT02861690

Liposomal Paclitaxel Combined Nedaplatin in Treatment of Advanced or Recurrent Esophageal Carcinoma

A Phase 2 study testing Liposomal Paclitaxel and Nedaplatin in people with Esophageal Carcinoma, run by Sun Yat-sen University at 1 site in China.

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

The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Carcinoma
What is being tested?
Liposomal Paclitaxel and Nedaplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
Jan 2010to Jan 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histological confirmed advanced metastatic or recurrent esophageal cancer
  • age between 18 and 80 years
  • ECOG performance status of 0 to 2
  • life expectancy ≥ 12 weeks
  • has evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
  • at least one prior chemotherapy regimen
Show all 10Show fewer
  • adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3
  • platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL
  • adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min,
  • adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN.

Who cannot join

  • other primary malignancy
  • symptomatic central nervous system metastasis
  • pregnancy or lactation
  • cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure
  • ongoing infection

Trial locations and contacts

1 site in 1 country.

China1 site

  • Medical Oncology,Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Phase II Study of Liposomal Paclitaxel With Nedaplatin as First-line in Advanced or Recurrent Esophageal Carcinoma

The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma

Read the detailed description

The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma.Patients receive Liposomal Paclitaxel 175mg/m2 and Nedaplatin 80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Being tested
Liposomal Paclitaxel, Nedaplatin
Keywords
Esophageal Cancer, nedaplatin, Liposomal Paclitaxel
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Liposomal PaclitaxelDrug

    Patients received Liposomal Paclitaxel 175mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

  • NedaplatinDrug

    Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Study groups in NCT02861690
Study groupRoleWhat they receive
Treatment groupExperimentalpatients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity
Receives: Drug: Liposomal Paclitaxel; Drug: Nedaplatin

What is being measured

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

  1. Response rate

    To assess the response rate of Liposomal Paclitaxel and Nedaplatin in patients with pretreated advanced or recurrent esophageal carcinoma. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

    Measured: from date of baseline measured to date of first CT evaluation，Up to 3 months

Secondary outcomes (3)

  1. progression-free survival

    Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment.

    Measured: from date of baseline to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  2. overall survival

    Overall survival is defined as the time from the date of study enrollment to the date of death from any cause.

    Measured: baseline to date of death from any cause，up to 2 approximately years

  3. Number of Participants With Adverse Events (Toxicity)

    Number of participants with treatment-related adverse events as assessed by CTCAE.

    Measured: Up to 30 days post last dose

Timeline

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

  1. First posted10 Aug 2016 (estimated)
  2. Study startJan 2010
  3. Primary completionSep 2015
  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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02861690
Sponsor's protocol ID
Esophageal cancer 001
Status last verified
Aug 2016
First submitted
28 Jul 2016
Last updated
10 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liposomal Paclitaxel and Nedaplatin in people with Esophageal Carcinoma, run by Sun Yat-sen University at 1 site in China.

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 10 inclusion and 5 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 10 Aug 2016. 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 China. 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 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 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?

Response rate (time frame: from date of baseline measured to date of first CT evaluation，Up to 3 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 NCT02861690.

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 10 Aug 2016.

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