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

NCT01869023 | Unknown Phase 2

• 1 other identifier: INCANOGAR2012-JA3
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Advanced Malignant Pleural Mesothelioma

Keywords

Advanced Malignant Pleural Mesothelioma; Gemcitabine and cisplatin; Gemcitabine continuous infusion

Outcome Measures

Primary Outcomes (1)

• Evaluate adverse effects to 250 mg/m2 infusion gemcitabine

  2 years

Secondary Outcomes (2)

• Progression Free Survival

  2 years

• overall survival

  2 years

Study Arms (1)

6 h infusion Gemcitabine and Cisplatin

OTHER

Gemcitabine 250 mg/m2 Cisplatin 30 mg/m2

Drug: Gemcitabine; Drug: Cisplatin

Interventions

Gemcitabine DRUG

Combination of Gemcitabine 250 mg/m2 in six hour infusion with cisplatin 35 mg/m2 administered day 1 and 8, for six cycles.

Also known as: Gemzar

6 h infusion Gemcitabine and Cisplatin

Cisplatin DRUG

Cisplatin 35 mg/m2SC applied on day 1 of 3 weeks cycles

Also known as: Platinol

6 h infusion Gemcitabine and Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Instituto Nacional de Cancerología

Mexico City, Mexico

Location

Related Publications (1)

• Arrieta O, Lopez-Macias D, Mendoza-Garcia VO, Bacon-Fonseca L, Munoz-Montano W, Macedo-Perez EO, Muniz-Hernandez S, Blake-Cerda M, Corona-Cruz JF. A phase II trial of prolonged, continuous infusion of low-dose gemcitabine plus cisplatin in patients with advanced malignant pleural mesothelioma. Cancer Chemother Pharmacol. 2014 May;73(5):975-82. doi: 10.1007/s00280-014-2429-5. Epub 2014 Apr 1.

  PMID: 24687408 DERIVED

MeSH Terms

Interventions

Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Oscar Arrieta, MD

  Instituto de Cancerología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Oncology Department

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: June 5, 2013
• Study Start: November 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)