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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00614835
First received: January 31, 2008
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

This is a pilot study of adjuvant therapy for patients with leiomyosarcoma of the uterus that has been completely removed by surgery. "Adjuvant" therapy means that the tumor (the leiomyosarcoma) has been completely removed by surgery; thus, giving further treatment now is done in hopes of decreasing the chance that the tumor will come back (relapse or recur). The main goal of this study is to show that this series of treatments is safe for patients with your type of tumor.

In this trial you will be getting drugs that have been approved for use in some types of cancer. In this study we wish to see whether the combination of two chemotherapy drugs, docetaxel and gemcitabine can decrease the chance of your tumor, leiomyosarcoma of the uterus, from coming back (relapsing). We will also be looking at the short-term side effects and risks of the drugs given in this combination to patients with leiomyosarcoma that has been completely resected (removed by surgery).

The combination of gemcitabine and docetaxel has been shown to be safe, and it has been shown to decrease the size of leiomyosarcoma tumors in patients with leiomyosarcoma of the uterus that has relapsed, or has continued to grow despite treatment with other chemotherapy drugs.


Condition Intervention
Uterine Leiomyosarcoma
Uterine Cancer
Drug: Docetaxel plus Gemcitabine

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine the tolerability of delivering 4 cycles of docetaxel plus gemcitabine. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the percentage of pts with completely resected uterine LMS tx with the regimen that remain progression-free at 2 years, & compare this rate with historical controls to establish an estimate of the efficacy of the adjuvant treatment strategy. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2001
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 patients with completely resected uterine leiomyosarcoma
Docetaxel plus Gemcitabine
Drug: Docetaxel plus Gemcitabine
Gemcitabine 900 mg/m2 IV over 90 minutes day 1 Gemcitabine 900 mg/m2 IV over 90 minutes day 8 + Docetaxel 75 mg/m2 IVPB day 8 Dexamethasone 8 mg po bid days 7-9 GCSF 150 ug/m2 (round to nearest vial size: 350 ug or 480 ug) SQ days 9-15 Repeat every 21 days for total of 4 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614835

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Martee Hensley, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00614835     History of Changes
Other Study ID Numbers: 01-098
Study First Received: January 31, 2008
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Gemcitabine
Docetaxel
uterine sarcoma

Additional relevant MeSH terms:
Leiomyosarcoma
Uterine Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 28, 2014