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A Pilot Study of Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus


N/A
18 Years
N/A
Not Enrolling
Female
Uterine Leiomyosarcoma, Uterine Cancer

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Trial Information

A Pilot Study of Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus


Inclusion Criteria:



- Pathologically confirmed leiomyosarcoma of the uterus, completely resected, stage I,
II, III or IV within 8 weeks of surgery to remove the tumor(s). Patients with stage I
tumors should have LMS that is considered high-grade by histology.

- No prior chemotherapy for LMS

- No prior treatment with gemcitabine or docetaxel Age > 18 years

- Karnofsky performance status (KPS) > or equal to 80%

- Pre-treatment absolute neutrophil count > or equal to 1500/ul, hemoglobin greater
than or equal to 8.0 gm/dl, and platelets > than or equal to 100,000/ul.

- Adequate renal documented by serum creatinine < than or equal to 2.0 mg/dL

- Adequate hepatic function: Total serum bilirubin must be within institutional normal
limits; transaminases (ALT and AST) may be up to 2.5 x institutional upper limit of
normal (ULN) if alkaline phosphatase is < than or equal to ULN, or alkaline
phosphatase may be up to 4 x ULN if transaminases are < than or equal to ULN.

If peripheral neuropathy is present, it must be less than or equal to grade 1

- Capable of providing written, informed consent

- Women with child-bearing potential must have a negative pregnancy test and must
consent to using effective contraception while on treatment and for a reasonable
period there after.

Exclusion Criteria:

- Active, or uncontrolled infection

- Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded. Prior radiation for localized cancer of the breast, head and
neck, or skin is permitted, provided that it was completed more than 3 years prior to
registration, and the patient remains free of recurrent or metastatic disease.

- Patients who have received prior chemotherapy for any abdominal or pelvic tumor are
excluded. Patients may have received prior adjuvant chemotherapy for localized breast
cancer, provided that it was completed more than 3 years prior to registration, and
that the patient remains free of recurrent or metastatic disease.

- With the exception of non-melanoma skin cancer and other specific malignancies as
noted above, patients with other invasive malignancies who had (or have) any evidence
of the other cancer present within the last 3 years or whose previous cancer
treatment contraindicates this protocol therapy are excluded.

- Known history of hypersensitivity reaction to docetaxel or other drugs formulated
with polysorbate 80, or history of hypersensitivity reaction to gemcitabine.

- Currently has grade 2, 3 or 4 neuropathy

- Pregnant or lactating women

- Known history of congestive heart failure

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the tolerability of delivering 4 cycles of docetaxel plus gemcitabine.

Outcome Time Frame:

conclusion of the study

Safety Issue:

Yes

Principal Investigator

Martee Hensley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

01-098

NCT ID:

NCT00614835

Start Date:

August 2001

Completion Date:

January 2012

Related Keywords:

  • Uterine Leiomyosarcoma
  • Uterine Cancer
  • Gemcitabine
  • Docetaxel
  • uterine sarcoma
  • Leiomyosarcoma
  • Uterine Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021