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Ph III Random Trial of 120-Min Infusion Gemcitabine v. 90-Min Infusion Gemcitabine + Docetaxel in Unresectable Soft Tissue Sarcoma: A Multi-Disciplinary Trial of the North Amer. Sarcoma Study Group of the Connective Tissue Oncology Society


Phase 3
10 Years
N/A
Not Enrolling
Both
Sarcoma, Soft Tissue

Thank you

Trial Information

Ph III Random Trial of 120-Min Infusion Gemcitabine v. 90-Min Infusion Gemcitabine + Docetaxel in Unresectable Soft Tissue Sarcoma: A Multi-Disciplinary Trial of the North Amer. Sarcoma Study Group of the Connective Tissue Oncology Society


This research is being done because better treatments for sarcomas are needed. This is a
phase III study. This means that one treatment is being compared to another to find out
which is better. We are comparing the drug gemcitabine to the two drugs gemcitabine and
docetaxel to find out which treatment is better for people who have sarcomas. From previous
studies we know that gemcitabine causes shrinking of some people's sarcoma tumors. We also
know that gemcitabine and docetaxel are useful for sarcomas as well, but we believe the two
drugs together may be more toxic than the single drug alone. In this study we are trying to
answer the question: "Is the combination of gemcitabine and docetaxel any better than just
gemcitabine alone?"

This is a randomized Phase III trial comparing two treatment regimens in patients with
unresectable soft tissue sarcoma. The failure rates observed on both treatment arms (failure
defined as progression or death) will be compared to determine which regimen results in the
lowest failure rate (Primary objective). As a secondary endpoint, the percentage of
patients who are failure-free (failure defined as progression or death) at 3 months and 6
months will be compared between the two arms (Secondary objective).

This trial, sponsored by the North American Sarcoma Study Group of the Connective Tissue
Oncology Society, is being done at a number of hospitals around the country and is expected
to enroll up to 120 patients.


Inclusion Criteria:



- Histologically proven soft tissue sarcoma (except the following histologies:
gastrointestinal stromal tumors (GIST), Kaposi's Sarcoma, mesotheliomas

- Age >= 10 years

- Recurrent or progressive disease defined as an increase in size of any existing tumor
mass, or the development of new tumor mass or masses, which is not amenable to
definitive surgical therapy.

- Patients may have had another cancer but there must be convincing clinical evidence
that the sarcoma is the disease requiring therapeutic intervention. (ie. Several
sarcoma patients have had had a prior cancer (Hodgkin's disease or breast cancer)
treated years previously and then developed a clinically active sarcoma.)

- Patients may have failed no more than 3 prior chemotherapy regimens.

- Measurable disease as defined by RECIST. Measurable disease is the presence of at
least one measurable lesion. If the measurable disease is restricted to a solitary
lesion, its neoplastic nature should be confirmed by cytology/histology. A measurable
lesion is one that can be accurately measured in at least one dimension with longest
diameter >20 mm using conventional techniques or >10 mm with spiral CT scan.

- Karnofsky performance status of greater than or equal to 60%

- Peripheral neuropathy, if present, must be < or = to grade 1

- At least 3 weeks since prior chemotherapy (10 days if the patient was on imatinib,
thalidomide, or an interferon)

- At least 3 weeks since prior radiation therapy

- Absolute neutrophil count > 1,500/mm3

- Hemoglobin > 8.0 g/dl

- Platelet count > 100,000/mm3

- Total Bilirubin < upper limit of normal (ULN).

- ALT (SGOT) or AST (SGPT) <5 x ULN.

- Alkaline Phosphatase < 2.5 x ULN.

- Serum creatinine < or equal to 2.0 mg/dL

- Women of child-bearing potential must have a negative serum pregnancy test

- Men and women of child-bearing potential must be willing to consent to using
effective contraception while on treatment and for a reasonable period thereafter
(approximately 3 months)

- If the patient is 18 or older, the patient must be capable of providing written,
informed consent. If the patient is younger than 18, written and voluntary informed
consent from patient's parents or legal guardians and the patient's assent are
required.

Exclusion Criteria:

- Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors
(GIST), Kaposi's sarcoma, mesotheliomas

- Active or uncontrolled infection (on antibiotic therapy for acute or chronic
infection)

- Prior treatment with gemcitabine or docetaxel

- Peripheral neuropathy > or = grade 2

- History of known hypersensitivity reaction to agents formulated in polysorbate 80,
the solubilizing agent for docetaxel [e.g. interferon alpha-2a, children's ibuprofen
suspension (Advil), terconazole (Terazol), lamivudine (Epivir), etoposide,
amiodarone, vaccines (DtaP, influenza), bupropion (Wellbutrin), Vitamins B12,
C+zinc+selenium].

- Uncontrolled, central nervous system metastases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine whether the failure rate (defined as progression or death) among patients with unresectable soft tissue sarcoma is improved with gemcitabine plus docetaxel compared with gemcitabine alone

Principal Investigator

Robert Maki, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

02-129

NCT ID:

NCT00142571

Start Date:

January 2003

Completion Date:

September 2007

Related Keywords:

  • Sarcoma, Soft Tissue
  • Sarcoma, Soft Tissue
  • Gemcitabine
  • Docetaxel
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021