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

Phase 2
18 Years
75 Years
Open (Enrolling)
Advanced Malignant Pleural Mesothelioma

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Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate adverse effects to 250 mg/m2 infusion gemcitabine

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Oscar Arrieta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto de Cancerología


Mexico: Ethics Committee

Study ID:




Start Date:

November 2010

Completion Date:

September 2014

Related Keywords:

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