Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC05-128 | Other Identifier | Memorial Sloan-Kettering Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.
Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemcitabine/docetaxel then doxorubicin | Other | Gemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine, docetaxel, doxorubicin | Drug | Cycles = 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS | Every 3 months up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability/Toxicity of This Regimen | Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue. | Every 28 days during dosing and then every 3 months thereafter until patient comes off study |
| Correlation Between Age and Tumor Response to Treatment (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martee L. Hensley, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Cancer Institute/Washington Hospital Center (Medstar) | Washington D.C. | District of Columbia | 20010 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23335221 | Derived | Hensley ML, Wathen JK, Maki RG, Araujo DM, Sutton G, Priebat DA, George S, Soslow RA, Baker LH. Adjuvant therapy for high-grade, uterus-limited leiomyosarcoma: results of a phase 2 trial (SARC 005). Cancer. 2013 Apr 15;119(8):1555-61. doi: 10.1002/cncr.27942. Epub 2013 Jan 18. |
| Label | URL |
|---|---|
| SARC Website | View source |
Not provided
Not provided
This was multi-center study open at 11 major medical centers across the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Women Treated With Adjuvant Regimen for High Risk Uterine LMS | Gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 minutes, followed by Docetaxel 75 mg/m2 on day 8 intravenously over 1 hour. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 years |
| Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS) | 2 years |
| Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS) | AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only | 2 years |
| Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS) | Mitotic rate is measured in mitoses per 10 high-power fields | 2 years |
| Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS) | 2 years |
| Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS) | 2 years |
| Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS) | Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread) | 2 years |
| Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS) | 2 years |
| H. Lee Moffitt Cancer Center and Research Institute |
| Tampa |
| Florida |
| 33612 |
| United States |
| Winship Cancer Institute at Emory University | Atlanta | Georgia | 30308 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| St. Vincent Gynecologic Oncology | Indianapolis | Indiana | 46260 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 01225 | United States |
| Massachusetts General | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Pennsylvania Oncology Hematology Associates | Philadelphia | Pennsylvania | 19106 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Women Treated With Adjuvant Regimen for High Risk Uterine LMS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS | Posted | Number | 95% Confidence Interval | percentage of participants | Every 3 months up to two years |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tolerability/Toxicity of This Regimen | Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue. | Posted | Number | number of major toxicity events | Every 28 days during dosing and then every 3 months thereafter until patient comes off study |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Age and Tumor Response to Treatment (PFS) | Posted | Median | Full Range | years | 2 years |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS) | Posted | Number | participants | 2 years |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS) | AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only | Posted | Number | participants | 2 years |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS) | Mitotic rate is measured in mitoses per 10 high-power fields | Posted | Median | Full Range | mitoses per 10 high-power fields | 2 years |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS) | Only 38 of the 47 patients were evaluable | Posted | Number | participants | 2 years |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS) | Only 38 of the 47 patients were evaluable | Posted | Number | participants | 2 years |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS) | Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread) | Posted | Number | participants | 2 years |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS) | Posted | Number | participants | 2 years |
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women Treated With Adjuvant Regimen for High Risk Uterine LMS | 9 | 47 | 14 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation of bowel | Gastrointestinal disorders |
| |||
| Hernia | Injury, poisoning and procedural complications |
| |||
| Colostomy Reversal | Gastrointestinal disorders |
| |||
| Chest Pain | Cardiac disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Neutrophils | Investigations |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Throat Pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Bilirubin | Investigations |
| |||
| Platelets | Investigations |
| |||
| Fever | General disorders |
| |||
| Infection | Infections and infestations |
| |||
| Blood clot | Blood and lymphatic system disorders |
| |||
| Renal insufficiency | Blood and lymphatic system disorders |
| |||
| Cellulitis | Skin and subcutaneous tissue disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myelosuppression | Endocrine disorders |
| |||
| Hypersensitivity | Immune system disorders |
| |||
| neuropathy | Nervous system disorders |
| |||
| Edema | Skin and subcutaneous tissue disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Project Manager | SARC | (734) 930-7600 | sarc@sarctrials.org |
| ID | Term |
|---|---|
| D007890 | Leiomyosarcoma |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Premenopausal |
|
|
| AJCC Stage I |
|
| AJCC Stage II |
|
| AJCC Stage III |
|
|
|
|
|
| Negative Status |
|
|
|
| Negative Status |
|
|
| Denominators |
|---|
| Categories |
|---|
| FIFO Stage I |
| |||||
| FIGO Stage II |
| |||||
| FIGO Stage III |
|
|
|
| ER and PR Negative |
|
|