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Study Summary
No. 2007-0424:.......Sarcoma......Shreyaskumar R. Patel......Sarcoma Medical Oncology
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Study Summary Title
Study Summary
Number:
2007-0424
Study Title:Protocol H8K-MC-JZAD
A Phase 2 Study of LY573636-sodium Administered as
Second or Third-line Treatment in Patients with
Unresectable or Metastatic Soft Tissue Sarcoma
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Physician New Patient Referral
Name:Shreyaskumar R. PatelPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Sarcoma Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-3626
Contact us about clinical trials
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General Information
Disease Group:SarcomaSupported By:Eli Lilly and Company
Phase of Study:Phase IIReturn
Visit:
Prestudy visit, and at the beginning of each cycle. Labwork on days 1,8, and
15 of each cycle. Post treatment visit at about 30 days after last dose of
study drug. Then, follow up visits every 60 days.
Treatment
Agents:
LY573636Home Care:Patients should receive supportive care during the trial;this may include
antibiotics, antiemetics, antidiarrheals, analgesics, and other interventions
as necessary.
Labwork on day 8 and 15 of each cycle.
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
None
Description/
Intervention:
The goal of this clinical research study is to learn if LY573636 can help to
control the disease in patients with soft tissue sarcoma that has moved to
other parts of the body or is not able to be removed by surgery. The safety of
this drug will also be studied.
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Study Objectives / Outcomes
Primary Objective
The primary objective of this study is to estimate median progression-free survival for patients who have received LY573636 after one or two prior systemic treatment regimens for unresectable or metastatic soft tissue sarcoma (STS), one of which must have been doxorubicin-based.

Secondary Objectives
The secondary objectives are:
  • to characterize the progression-free survival distribution
  • to estimate the objective response rate (complete response [CR] and partial response [PR]) and clinical benefit rate ([CR+PR+stable disease (SD)])
  • to evaluate the pharmacokinetics of LY573636 using a limited sampling methodology in this population
  • to estimate time-to-event variables, such as overall survival time, duration of overall objective response and duration of stable disease
  • to evaluate the safety of LY573636 in this patient population.
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Study Status Information
Study Activation / Registration Date:01/11/2008
IRB Review and Approval Date:10/23/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:75
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Have a histologic and/or cytologic diagnosis of soft tissue sarcoma that is unresectable or metastatic.

2) Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

3) Are at least 18 years of age.

4) Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.

5) Have received no more than two previous systemic treatment regimens for metastatic soft tissue sarcoma, one of which must have been doxorubicin-based. For purposes of eligibility, neoadjuvant chemotherapy is not counted toward determining the number of prior systemic treatment regimens.

6) Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia).

7) Have adequate organ function including: Bone Marrow Reserve: Absolute neutrophil count (ANC) >/=1.5 x 10^9/L prior to treatment, platelets >/=100 x 10^9/L, and hemoglobin >/=8 g/dL (transfusions are not allowed to reach 8 g/dL prior to enrollment). Hepatic: Bilirubin </= 1.5 times the upper limit of normal (ULN). Alkaline phosphatase and transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) </= 5 times ULN. Renal:Serum creatinine at or below the ULN. No known active renal disease.

8) Have a serum albumin level >/= 3.3 g/dL (33 g/L).

9) Males and females with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug.

10) Exhibit patient compliance and geographic proximity that allow for adequate follow-up.

11) Have given written informed consent approved by Lilly and the Institutional Review Board/Ethical Review Board (IRB/ERB) governing the site.

Exclusion Criteria:1) Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

2) Have received > 2 previous systemic treatment regimens for metastatic soft tissue sarcoma. For purposes of eligibility, neoadjuvant chemotherapy is not counted toward determining the number of prior systemic treatment regimens.

3) Patients with primary bone sarcoma (e.g., osteosarcoma, Ewing's sarcoma, chondrosarcoma), gastrointestinal stromal tumor (GIST), and Kaposi's sarcoma.

4) Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed prior to study entry to rule out occult brain metastasis.

5) Patients with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).

6) Patients with a second primary malignancy that could affect compliance with the protocol or interpretation of the results. NOTE: Patients with adequately treated carcinoma of the skin (excluding melanoma) and patients with a prior history of malignancy who have been disease-free for more than 2 years are eligible.

7) Patients with serious preexisting medical conditions (at the investigator's discretion).

8) Patients receiving warfarin (Coumadin ®) therapy.

9) Persons who have previously completed or withdrawn from this study or any other study investigating LY573636.

10) Women who are pregnant or lactating.

11) Patients with a serum albumin < 3.3 g/dL (33 g/L) at time of study entry.

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Links
Registration Number: NCT00490451
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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