A Phase 2 interventional study of Gemcitabine Hydrochloride and Docetaxel in Recurrent Uterine Corpus Sarcoma and Uterine Carcinosarcoma, sponsored by Gynecologic Oncology Group. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2019-01-08.
Sponsored by Gynecologic Oncology Group · Phase 2, Interventional, and Treatment
This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
OBJECTIVES:
I. Determine the antitumor activity of gemcitabine and docetaxel in patients with recurrent or persistent uterine carcinosarcoma.
II. Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study. Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-4 years.
75 studies on the registry are indexed under Carcinosarcoma; 10 are open to participants now.
This study's enrollment of 28 is below the median of 50 across 64 interventional studies indexed under Carcinosarcoma.
Browse Carcinosarcoma studies →Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Histologically confirmed uterine carcinosarcoma
Recurrent or persistent disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Received 1, and only 1, prior chemotherapy regimen for carcinosarcoma
Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Drug: Gemcitabine Hydrochloride · Drug: Docetaxel
Given IV
Also known as: dFdC, dFdCyd
Given IV
Also known as: TXT
Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time frame: CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.
Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Count of participants with Toxicities maximum grade greater than or equal to grade 3
Time frame: Assessed every 28 days (28 days=1 cycle) while on study treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
This trial was opened to patient entry on March 7, 2005 and was closed to accrual on October 29, 2007
| Milestone | Treatment (Gemcitabine Hydrochloride, Docetaxel) |
|---|---|
| Started | 28 |
| Completed | 24 |
| Not completed | 4 |
| Withdrew: Wrong cell type | 2 |
| Withdrew: Wrong primary | 1 |
| Withdrew: Never treated | 1 |
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
| Percentage of participants | Treatment (Gemcitabine Hydrochloride, Docetaxel) |
|---|---|
| Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0 | 8 (1 to 27) |
Count of participants with Toxicities maximum grade greater than or equal to grade 3
| Participants | Treatment (Gemcitabine Hydrochloride, Docetaxel) |
|---|---|
| Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | 18 |
Collected over AEs were assessed every 28 days (1cycle) while on study treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Gemcitabine Hydrochloride, Docetaxel) | — | 11/24 (45.8%) | 22/24 (91.7%) |
| Event | Treatment (Gemcitabine Hydrochloride, Docetaxel) |
|---|---|
| ConstipationGastrointestinal disorders | 2/24 |
| Death No CTCAE Term-Sudden DeathGeneral disorders | 2/24 |
| FatigueGeneral disorders | 2/24 |
| Death No CTCAE Term -Disease Progression NOSGeneral disorders | 2/24 |
| Pain: Extremity-LimbGeneral disorders | 1/24 |
| Pain -BackGeneral disorders | 1/24 |
| BilirubinInvestigations | 1/24 |
| Alkaline PhosphataseInvestigations | 1/24 |
| Hemorrhage, GI - LiverHepatobiliary disorders | 1/24 |
| Abdominal Pain NOSGeneral disorders | 1/24 |
| Event | Treatment (Gemcitabine Hydrochloride, Docetaxel) |
|---|---|
| AnemiaBlood and lymphatic system disorders | 20/24 |
| LeukopeniaBlood and lymphatic system disorders | 18/24 |
| NeutropeniaBlood and lymphatic system disorders | 18/24 |
| ThrombocytopeniaBlood and lymphatic system disorders | 15/24 |
| Other GastrointestinalGastrointestinal disorders | 14/24 |
| NauseaGastrointestinal disorders | 11/24 |
| AlopeciaSkin and subcutaneous tissue disorders | 10/24 |
| FatigueGeneral disorders | 9/24 |
| MetabolicMetabolism and nutrition disorders | 9/24 |
| NeurotoxicityNervous system disorders | 6/24 |
Eligible and treated patients
| Age, Customized(Participants) | Treatment (Gemcitabine Hydrochloride, Docetaxel) |
|---|---|
| <50 years | 2 |
| 50-59 years | 5 |
| 60-69 years | 12 |
| 70-79 years | 4 |
| >79 years | 1 |
| Sex: Female, Male(Participants) | Treatment (Gemcitabine Hydrochloride, Docetaxel) |
|---|---|
| Female | 24 |
| Male | 0 |
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