Gemcitabine as Maintenance Treatment for Diffuse Pleural Mesothelioma

NCT07411144 | Completed Phase 2 DMC

• 1 other identifier: GEMO-MPM-2025-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

What is this study about? This study looks at whether continuing chemotherapy with a drug called gemcitabine after initial treatment can help patients with diffuse pleural mesothelioma keep their cancer under control for a longer time. Diffuse pleural mesothelioma is a rare and aggressive cancer that affects the lining of the lungs. Even after standard chemotherapy, the disease often comes back quickly. Doctors are therefore looking for maintenance treatments that may delay cancer progression. What does this mean for patients and families? Gemcitabine maintenance treatment may help delay cancer progression It does not clearly extend overall life expectancy Side effects are common and should be carefully discussed with the treating oncologist Treatment decisions should consider: Patient performance status Symptoms Personal preferences and quality of life What does this mean for health care providers? Gemcitabine maintenance may be an option for: Fit patients Those who responded to first-line chemotherapy Careful patient selection is essential Monitoring for hematologic toxicity is required Further larger studies are needed to confirm survival benefit

Conditions

Diffuse Pleural Mesothelioma (DPM)

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Progression-free survival is defined as the time from randomization to the first documented disease progression according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) for pleural mesothelioma or death from any cause, whichever occurs first.

  From randomization until disease progression or death from any cause, up to 36 months

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Assessed every 8 weeks from randomization until disease progression, up to 24 months

• Treatment-Related Toxicity

  From first dose of study treatment until 30 days after treatment discontinuation

• Prognostic Factors Associated With Progression-Free and Overall Survival

  From randomization until death or end of follow-up, up to 36 months

Study Arms (2)

Gemcitabine Maintenance Therapy

EXPERIMENTAL

Patients received gemcitabine as maintenance therapy in addition to best supportive care following response or stable disease after first-line platinum-based chemotherapy.

Drug: Gemcitabine (1000 mg/m2)

Best Supportive Care

NO INTERVENTION

Patients received best supportive care alone, including symptom control and palliative measures, without active anti-cancer maintenance chemotherapy.

Interventions

Gemcitabine (1000 mg/m2) DRUG

Gemcitabine was administered intravenously as maintenance therapy following response or stable disease after first-line platinum-based chemotherapy. Treatment was continued until disease progression, unacceptable toxicity, or discontinuation for clinical reasons.

Gemcitabine Maintenance Therapy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Histologically confirmed unresectable diffuse pleural mesothelioma
• Complete response, partial response, or stable disease after 4-6 cycles of first-line platinum-based chemotherapy, according to modified RECIST (mRECIST) criteria
• Last dose of first-line chemotherapy administered within 60 days prior to randomization
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy of at least 12 weeks
• Adequate bone marrow function
• Adequate hepatic function
• Adequate renal function
• Ability to provide written informed consent

You may not qualify if:

• Prior extra-pleural pneumonectomy
• Evidence of active brain or leptomeningeal metastases
• Weight loss \>10% within 6 weeks prior to enrollment
• Clinically significant ascites
• Known hypersensitivity or intolerance to gemcitabine
• Receipt of non-palliative radiotherapy within 3 weeks before initiation of study treatment

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute, Cairo University

Cairo, Egypt, 11765, Egypt

Location

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mohamed Emam Sobeih, MD

  National Cancer Institute,Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No masking was applied to participants, investigators, or outcome assessors due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Medical Oncology

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel groups. One group received gemcitabine as maintenance therapy in addition to best supportive care, while the other group received best supportive care alone. Treatment allocation remained fixed throughout the study, and no crossover between groups was permitted.

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 13, 2026
• Study Start: March 15, 2020
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

EG (1)