NCT00614835

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

4.5 years

First QC Date

January 31, 2008

Last Update Submit

December 21, 2015

Conditions

Uterine LeiomyosarcomaUterine Cancer

Keywords

GemcitabineDocetaxeluterine sarcoma

Outcome Measures

Primary Outcomes (1)

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

    conclusion of the study

Secondary Outcomes (1)

  • 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.

    conclusion of the study

Study Arms (1)

1 patients with completely resected uterine leiomyosarcoma

EXPERIMENTAL

Docetaxel plus Gemcitabine

Drug: Docetaxel plus Gemcitabine

Interventions

Docetaxel plus GemcitabineDRUG

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

1 patients with completely resected uterine leiomyosarcoma

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

DocetaxelGemcitabine

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Martee Hensley, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

August 1, 2001

Primary Completion

February 1, 2006

Study Completion

January 1, 2012

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

US(1)