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AzTrials

Uterine Cervical CancerPhase 1/2NCT02095119

A Monoclonal Antibody, Nimotuzumab, as Treatment for Recurrent or Metastatic Cervical Cancer

A Phase 1/2 study testing Nimotuzumab, Cisplatin and Gemcitabine in people with Uterine Cervical Cancer, run by National Institute of Cancerología at 1 site in Mexico.

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 following is an open label, non comparative, pilot study of palliative treatment as a second, third line or more of treatment in patients with recurrent, persistent or Metastatic Cervical Cancer; it has a limited sample of 15 patients with the primary goal of evaluating the response (defined as: Complete, partial… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Cervical Cancer
What is being tested?
Nimotuzumab, Cisplatin and Gemcitabine
How many people
15 participants
Where
1 siteMexico
Study dates
Jul 2008to Mar 2014
Phase
Phase 1/2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who give their written consent of participation in this study.
  • Patients with recurrent or persistent cervical-uterine cancer, with local and/or systemic disease with measurable lesions, whether by physical examination, CT Scan or MRI detected at least in the previous 6 weeks. If there is only one lesion and it is less than 10 mm in length, a biopsy confirmation is required.
  • Patients currently receiving a second, third line or more of palliative chemotherapy diagnosed at least 30 days after the last chemotherapy.
  • Patients with one of the following Histopathological reports: Squamous Cell Carcinoma (epidermoid carcinoma), adenocarcinoma, adenosquamous carcinoma or glassy cell carcinoma.
  • Patients must be older than 18 years old.
  • ECOG score no worst than 3.
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  • Patients with life expectancy greater than 4 weeks.
  • Patients with left ventricle ejection fraction (LVEF) ≥ 50 measured by radioisotopic ventriculography.
  • Patients who meet all previous criteria with previously radiated metastatic disease in the central nervous system will be included.
  • Patients with normal functioning of the bone marrow and other organs as defined by the following parameters:
  • Hemoglobin ≥ 9 g/L
  • Leucocytes ≥ 4000/microL
  • Absolute neutrophil count ≥ 1500/microL
  • Platelet count ≥ 100000/microL
  • Total serum Bilirubin: up to 1.5 times the normal value
  • Total Proteins: Within normal limits
  • AST and ALT =/< 2.5 times the normal superior limit of the institutional laboratory
  • Serum creatinine: within normal limits or up to 2 mg and GFR ≥ 60ml/min calculated with the Cockcroft-Gault equation.

Who cannot join

  • Pregnant or nursing mothers.
  • Patients with cervical-uterine cancer with a histopathological report of: small cell carcinoma and/or neuroendocrine tumor.
  • Patients currently receiving another investigational onco-specific drug.
  • Patients with a history of allergy to chemical substances with similar chemical composition to that of the monoclonal antibody or chemotherapeutic agents used in this study.
  • Patients with non-controlled co-morbid states such as active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, uncompensated diabetes and/or psychiatric illness.
  • Presence of a second tumor. With the exception of those patients who have received adequate treatment for skin carcinomas (basal or squamous).
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  • Previous or concomitant malignancy except non-melanoma skin carcinoma.
  • Social, familiar or geographic conditions that suggest poor attachment to the study.
  • Discontinuation of treatment criteria:
  • At the patient´s request.
  • Progression of disease causing worsening of the patient´s overall status in non manageable clinical conditions, (ECOG worst than 3).
  • Death.
  • Discontinuation of monitoring and/or loss of patient follow-up for more than 2 months.
  • Severe adverse reaction grade 4 according to CTCAE.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Nacional de Cancerología

    Mexico City, Federal District, 14080

Other trials in Mexico

About this study

Official title: Phase I-II Study of Palliative Treatment With Nimotuzumab as a Second, Third Line or More of Treatment for Advanced or Metastatic Cervical Cancer

The following is an open label, non comparative, pilot study of palliative treatment as a second, third line or more of treatment in patients with recurrent, persistent or Metastatic Cervical Cancer; it has a limited sample of 15 patients with the primary goal of evaluating the response (defined as: Complete, partial or stable disease) to treatment with a Monoclonal Antibody, Nimotuzumab, on a weekly basis + CDDP 50mg/m2/BSA as a single agent every 3 weeks for patients with good renal function (Creatinine clearance => 60) or Gemcitabine 800 mg/m2/BSA in patients with renal failure (Creatinine clearance <60).

Secondary objectives consist of evaluating disease-free survival, overall survival and assess patient tolerance to treatment with Nimotuzumab.

Being tested
Nimotuzumab, Cisplatin, Gemcitabine, CT Scan
Keywords
Uterine cervical cancer, Palliative, Treatment, Monoclonal antibody, Nimotuzumab
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • NimotuzumabDrug

    Monoclonal antibody Nimotuzumab will be administered alone at a 200mg dose weekly during the first 4 weeks. Posteriorly it will be administered with a maintenance dose of 200 mg every 2 weeks in combination with chemotherapeutic agents Cisplatin in patients with good renal function or Gemcitabine in patients with kidney failure data until exclusion or death occurs. The administration will be intravenously in 250 ml of saline solution in a time period of 30 minutes.

  • CisplatinDrug

    Cisplatin will be administered at a calculated dose of 50mg/m2/BSA every 21 days as concomitant therapy to Nimotuzumab, until 6 cycles are completed, exclusion or death occurs, only in patients whose creatinine clearance as defined by the Cockcroft-Gault equation is >/= 60. The administration form will be intravenously.

  • GemcitabineDrug

    Gemcitabine will be administered at a calculated dose of 800 mg/m2/BSA every 21 days as concomitant therapy to Nimotuzumab, until 6 cycles are completed, exclusion or death occurs, in patients with kidney failure data(Creatinine clearance as defined by the Cockcroft -Gault equation < 60). The administration form will be intravenously.

  • CT ScanProcedure or surgery

    A CT Scan will be performed in all patients prior to the beginning of treatment to assess any measurable tumor found by this method. The CT Scan will be repeated once the patient completes the induction phase with Nimotuzumab (4 once a week doses), when the patient has completed 3 full cycles of combination therapy with Nimotuzumab (every 2 weeks)and Gemcitabine or Cisplatin (every 21 days)and once more when the patient has completed 6 full cycles of the aforementioned therapy.

What is being measured

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

  1. Antitumoral Response

    Treatment response will be evaluated according to the new International Criteria from Response Evaluation Committee in Solid Tumors (RESIST). Antitumoral response will be evaluated from patient´s inclusion after 4 weeks of induction therapy and then every 3 months until second year of follow up for each patient.

    Measured: After 4 weeks of induction therapy, and then every 3 months for a period of 2 years

Secondary outcomes (3)

  1. Progression Free Survival

    Progression Free Survival will be defined as the time elapsed since the beginning of interventions until progressive disease is documented by growth of measurable lesions or new lesions on CT Scan or MRI according to the response evaluation criteria in solid tumors (JNCI 92 (3): 205-216, 2000).

    Measured: After patient´s inclusion every 3 months for a period 2 years

  2. Overall Survival

    Patient´s survival since inclusion until death

    Measured: from patient´s inclusion until 24 months

  3. Drug Toxicity

    Drug toxicity will be assessed with hematologic, renal and hepatic laboratory measures as well as patient symptomatology and physical findings. Any abnormality in these parameters will be reported as an adverse event according to the Common Terminology Criteria for Adverse Events version 3.0(CTCAEV3.0, 2006)

    Measured: from patient´s inclusion every 2 weeks for a period of 2 years

Timeline

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

  1. First posted24 Mar 2014 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2013
  4. Study completionMar 2014

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02095119
Sponsor's protocol ID
INCAN/CC/130/09
Status last verified
Apr 2015
First submitted
17 Feb 2014
Last updated
14 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Cetina L, Crombet T, Jimenez-Lima R, Zapata S, Ramos M, Avila S, Coronel J, Charco E, Bojalil R, Astudillo H, Bazan B, Duenas-Gonzalez A. A pilot study of nimotuzumab plus single agent chemotherapy as second- or third-line treatment or more in patients with recurrent, persistent or metastatic cervical cancer. Cancer Biol Ther. 2015;16(5):684-9. doi: 10.1080/15384047.2015.1026483.

    PubMed 25802932

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nimotuzumab, Cisplatin and Gemcitabine in people with Uterine Cervical Cancer, run by National Institute of Cancerología at 1 site in Mexico.

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 18 inclusion and 14 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 14 Apr 2015. 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 Mexico. 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 combined 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.

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?

Antitumoral Response (time frame: After 4 weeks of induction therapy, and then every 3 months for a period of 2 years). 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 NCT02095119, 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 14 Apr 2015.

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