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Phase 1/2, Randomized, Multicenter, Prospective Study of Gemcitabine and Rapamycin (Sirolimus) Combination Versus Gemcitabine Only to Treat Advanced Soft Tissue Sarcoma


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Advanced Soft Tissue Sarcoma

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Trial Information

Phase 1/2, Randomized, Multicenter, Prospective Study of Gemcitabine and Rapamycin (Sirolimus) Combination Versus Gemcitabine Only to Treat Advanced Soft Tissue Sarcoma


Inclusion Criteria:



1. Patients with anatomopathological diagnosis of metastatic or locally advanced
unresectable soft tissue sarcoma (STS). Patients with the following STS types will be
excluded: chondrosarcoma, Ewing's sarcoma and embryonal or alveolar rhabdomyosarcoma.
In phase 1 it will be allowed to include patients having other types of advanced
cancer which are resistant to the standard treatment and can benefit from any of the
study drugs.

2. Prior treatment with chemotherapy including doxorubicin and ifosfamide, or
contraindication for its administration. The previous treatment with gemcitabine or
inhibitors of mTOR is not allowed.

3. Age ≥ 18 y ≤ 70 years.

4. ECOG performance status: 0 - 2. In Phase 1 only patients with ECOG 0-1 will be
enrolled.

5. Disease measurable according to RECIST criteria. Proven relapsed disease.

6. Adequate bone marrow function, defined as neutrophil count ≥ 1.500/mm^3 and platelets
≥ 100.000/mm^3.

7. Adequate renal and hepatic function , defined as calculated creatinine clearance ≥ 60
ml/min, creatinine, total bilirubin, AST and/or ALT ≤ 1,5 times the upper limit of
normal (ULN).

8. Informed consent form signed by the patient prior to the beginning of the treatment.

Exclusion Criteria:

1. History of previous cancer diagnosed or treated in the past 5 years except basal cell
carcinoma, cervical carcinoma in situ or superficial bladder cancer.

2. Presence of brain metastases.

3. Active infection or other severe concomitant diseases.

4. Concurrent treatment with other experimental drugs within 30 days prior to study
entry.

5. Pregnancy or breastfeeding.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Phase 1: Determination of dosage: Security and toxicity of the combination gemcitabine and rapamycin.

Outcome Description:

Type, frequency, seriousness and relation with the treatment of the adverse events in patients treated with the investigational medicinal products.

Outcome Time Frame:

15 months

Safety Issue:

Yes

Principal Investigator

Xavier García del Muro Solans, MD

Investigator Role:

Study Chair

Investigator Affiliation:

GEIS

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

GEIS-24

NCT ID:

NCT01684449

Start Date:

January 2010

Completion Date:

December 2013

Related Keywords:

  • Advanced Soft Tissue Sarcoma
  • Soft tissue sarcoma
  • Gemcitabine
  • Rapamycin
  • Sirolimus
  • mTOR inhibitor
  • Molecular biomarkers
  • Sarcoma

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