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Sarcoma, Soft TissuePhase 3NCT00142571

Comparison of Gemcitabine v. Gemcitabine Plus Docetaxel in Unresectable Soft Tissue Sarcoma

A Phase 3 study testing Gemcitabine and Docetaxel in people with Sarcoma, Soft Tissue, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the drug gemcitabine to two drugs, gemcitabine and docetaxel, to find out which treatment is better for people with sarcomas. Read more about this study

Who is it for?
Ages 10 years and older
Conditions the study is for
Sarcoma, Soft Tissue
What is being tested?
Gemcitabine and Docetaxel
How many people
120 participants
Where
1 siteUnited States
Study dates
Jan 2003to Sep 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: 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

The purpose of this study is to compare the drug gemcitabine to two drugs, gemcitabine and docetaxel, to find out which treatment is better for people with sarcomas.

Read the detailed description

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.

Being tested
Gemcitabine, Docetaxel
Keywords
Sarcoma, Soft Tissue, Gemcitabine, Docetaxel
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

Secondary outcomes (4)

  1. Determine whether the failure rate (defined as progression or death) at 3 and 6 months is improved among patients with unresectable soft tissue sarcoma treated with gemcitabine plus docetaxel compared with those treated with gemcitabine alone.

  2. Overall survival will be evaluated

  3. Response rate will be evaluated

  4. Toxicity will be evaluated

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2005 (estimated)
  2. Study startJan 2003
  3. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00142571
Sponsor's protocol ID
02-129
Status last verified
Oct 2007
First submitted
31 Aug 2005
Last updated
2 Oct 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemcitabine and Docetaxel in people with Sarcoma, Soft Tissue, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00142571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2007.

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