Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma

March 1, 2017 updated by: Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

Phase II Study of Six Hours, Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma.

Malignant pleural mesothelioma (MPM) is a rare disease, but with a very high mortality. MPM is frequently found in advanced stages. The standard treatment in advanced pleural mesothelioma is cisplatin-based chemotherapy combined with pemetrexed/raltitrexed (phase III studies showed its benefit in response and overall survival compared with cisplatin alone). There are other active drugs such as liposomal doxorubicin and gemcitabine. Unfortunately, cost is an important factor to consider in our population and standard treatments are very expensive. Gemcitabine 250 mg infused over 6 hrs in combination with cisplatin, compared to the standard administration of gemcitabine 1250 mg infusion of 30 minutes in NSCLC, combined with cisplatin showed 75 mg shown in a study to be equally effective in treating cancer non-small cell lung. A phase II study using this strategy for advanced MPM has shown promising results. Gemcitabine administered in low dose in a six hour infusion may reduce cost of treatment without altering the effectiveness.

Primary Objective.

-Evaluate the response of treatment with gemcitabine at a dose of 250 mg/m2SC in 6-hour infusion combined with cisplatin in patients with unresectable malignant mesothelioma.

Secondary objectives.

  • Evaluate toxicity of the combination of gemcitabine at a dose of 250 mg/m2 infused over 6 hours in with cisplatin in patients with unresectable malignant mesothelioma.
  • Evaluate the progression free survival (PFS) and overall survival (OS) in patients with unresectable MM treated with this combination.

Hypothesis:

Combination therapy of gemcitabine at a dose of 250 mg/m2 infusion of 6 hrs applied on day 1 and 8 combined with cisplatin 35 mg/m2SC applied on day 1 of 3 weeks cycles is a treatment that provides similar results in responses when compared with previous studies with the same combination therapy, but with a conventional administration (gemcitabine 1,250 mg in 30 minutes on days 1, 8 and 15).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Malignant pleural mesothelioma is a rare disease, but with a high mortality. It usually develops in people who were exposed to asbestos, with a latency period ranging from 20 to 40 years. Most of these patients present with advanced disease, which are considered unresectable and combination chemotherapy is the treatment of choice. Currently the standard treatment is the combination of pemetrexed with cispaltin, this treatment showed benefit in overall survival and overall response rate in comparison with the treatment with cisplatin alone. This standard chemotherapy in our country is difficult to access due to the costs of the treatment and the poor economic situation of most of our patients. That's why determining the effectiveness of other treatment options that have shown activity in this disease that are less expensive, is of vital importance in our country. Phase I studies of gemcitabine showed that the maximum tolerated dose varies with time of infusion, 250 mg/m2 is the maximum tolerated dose when the infusion is carried out in 6 hours, as opposed to 1250 mg/m2 when gemcitabine is administered in a conventional manner . A phase III study in NSCLC, which compared the administration of gemcitabine infusion of 250 mg/m2 in 6 hours versus conventional administration of 1,250 mg/m2 in 30 minutes showed that both treatments were similar in efficacy and toxicity. The same group conducted a phase II study in unresectable malignant pleural mesothelioma that was published recently with promising results. That is why we decided to conduct a phase II study in patients with unresectable malignant pleural mesothelioma with the idea of validating the results previously obtained and to study factors and associated with resistance to chemotherapy as ERCC1, RPM1, thymidylate synthase.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de Cancerologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic Diagnosis of Pleural Mesothelioma
  • Multidisciplinary assessment and considered not candidate for resection.
  • Karnofsky > = 70 or ECOG < 2
  • Adequate Hematologic, renal and hepatic function.

Exclusion Criteria:

  • Superior vena cava syndrome, severe bone pain or CNS metastasis
  • Not candidate for chemotherapy (Poor functional status: ECOG > 2)
  • The patient refuses to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 6 h infusion Gemcitabine and Cisplatin
Gemcitabine 250 mg/m2 Cisplatin 30 mg/m2
Drug: Gemcitabine
Combination of Gemcitabine 250 mg/m2 in six hour infusion with cisplatin 35 mg/m2 administered day 1 and 8, for six cycles.
Other Names:
  • Gemzar
Drug: Cisplatin
Cisplatin 35 mg/m2SC applied on day 1 of 3 weeks cycles
Other Names:
  • Platinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate adverse effects to 250 mg/m2 infusion gemcitabine
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 2 years
2 years
overall survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Collaborators

National Council of Science and Technology, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

May 31, 2013

First Posted (ESTIMATE)

June 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCANOGAR2012-JA3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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