NCT02083211

Brief Summary

This study evauates the global survival of patients following administration of mAb Nimotuzumab hR3 + chemotherapy in the treatment of cervical cancer in first line therapy, after relapsing from chemo-radiotherapy. It is a Phase III, multi-centric, randomized, double blind study; 168 patients will be assigned to Nimotuzumab + Cisplatin/Vinorelbine or placebo + Cisplatin/Vinorelbine. After progression, a second line chemotherapy based on carboplatino/taxol will be administered in both groups. Concomitant administration of Nimotuzumab will be continued every 14 days until limiting toxicity or ECOCG \>3. Tumor markers such as Kras, p53, KI67, and EGFR will be identified. Cardiac toxicity will be evaluated using MRI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

3.8 years

First QC Date

February 17, 2014

Last Update Submit

April 13, 2015

Conditions

Cervical Cancer Recurrent or PersistentPalliative TreatmentMonoclonal Antibody in Cervical Cancer Treatment

Keywords

Cervical cancerRecurrent or persistent tumorMonoclonal antibody

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Patient's survival since inclusion until death.

    11 months

Secondary Outcomes (4)

  • Illness free survival

    6 months

  • Antitumoral Response

    6 months

  • Progression free survival

    3 months

  • Safety

    Every 2 weeks for a period of 3 years

Study Arms (2)

mAb Nimotuzumab + chemotherapy

EXPERIMENTAL
Drug: mAb Nimotuzumab

placebo + chemotherapy

PLACEBO COMPARATOR
Device: Placebo

Interventions

mAb NimotuzumabDRUG

This group will receive a dose of 200 mg mAb hR3 (weekly over 18 weeks) plus chemotherapy (6 cycles every 21 days of Cisplatin (CDDP) 50 mg/m2 on day 1/, Vinorelbine 30 mg/m2 on day 1 and day 8)

mAb Nimotuzumab + chemotherapy
PlaceboDEVICE

This group will receive a placebo in addition to chemotherapy in a similar regimen. Once the chemotherapy is completed a maintenance dose will be administered with 200 mg/dose of mAb hR3 every 14 days until progression.

placebo + chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who grant their written consent to participate in the trial;
  • With persistent or recurrent local and/or systemic cervical cancer with a measurable disease through physical examination, CAT, or MRI;
  • Diagnosed 90 days after concluding administration of chemotherapy + radotherapy to pelvis or pelvic extended fields chemo-radiotherapy;
  • Pathological report with epidermal carcinoma, adenocarcinoma, adenosquamous carcinoma and glassy cell carcinoma;
  • ECOG Performance Status ≤2;
  • Life expectancy \>6 months;
  • LVEF \>50 (MUGA or ecocardiogram)
  • Normal function of organs and of bone marrow defined by laboratory parameters.

You may not qualify if:

  • Pregnant or breastfeeding patients;
  • Small cells and/or neuroendocrine cervical cancer;
  • Receiving other oncospecific drug under research;
  • Allergy history to compounds of chemical or biological similar composition to the monoclonal antibody being evaluated or to chemotherapeutic agents;
  • Intercurrent non controlled diseases including active infections, symptomatic congestive cardiac failure, unstable angina pectoris, cardiac arrhythmia, decompensated diabetes and psychiatric disorders.
  • With a second tumor; except for those who have received appropriate treatment for skin carcinomas (basal or squamous).
  • Previous or concomitant malignancy except for non-melanoma skin carcinoma.
  • Social, family or geographic conditions that suggest a poor study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cancerología

México, Tlalpan, 14080, Mexico

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC, MD

Study Record Dates

First Submitted

February 17, 2014

First Posted

March 11, 2014

Study Start

July 1, 2010

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

ME(1)