- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00025506
Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus
A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES: Primary I. Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine carcinosarcoma.
II. Determine the nature and degree of toxicity of this drug in these patients.
Secondary I. Determine the partial and complete response rates in patients treated with this drug.
II. Determine the duration of PFS and overall survival of patients treated with this drug.
III. Determine the effect of this drug on initial performance status and histological grade in these patients.
IV. Correlate serum and plasma biomarkers, including vascular endothelial growth factor and basic fibroblast growth factor, with clinical outcome (i.e., PFS) in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 3 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Gynecologic Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed uterine sarcoma
Carcinosarcoma (malignant mixed müllerian tumor)
- Homologous or heterologous type
- Recurrent or persistent with documented disease progression after prior local therapy
At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI
- At least 10 mm by spiral CT scan
- Tumors within a previously irradiated field are considered non-target lesions
- Must have received 1 prior initial chemotherapy regimen (including high-dose ,consolidation, or extended therapy after surgical or nonsurgical assessment) for carcinosarcoma
No documented brain metastases since diagnosis of cancer
- Patients with stable CNS deficits are allowed provided that there is no evidence of brain metastases on CT scan or MRI
- Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), including any active phase III GOG protocol for the same patient population
- Performance status - GOG 0-2 if received 1 prior therapy regimen
- Performance status - GOG 0-1 if received 2 prior therapy regimens
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance greater than 60 mL/min
- Not pregnant
- Negative pregnancy test
- Fertile patients must use at least 1 highly active method of contraception and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation
No seizure disorders since diagnosis of cancer
- Patients with a history of seizure disorders are allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen
- No active infection requiring antibiotics
- No greater than grade 1 sensory or motor neuropathy
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- At least 3 weeks since prior immunologic agents for uterine sarcoma
- No prior thalidomide
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy for uterine sarcoma and recovered
- No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine sarcoma
- No prior non-cytotoxic chemotherapy for recurrent or persistent uterine sarcoma
- No concurrent bisphosphonates (e.g., zoledronate)
- At least 1 week since prior hormonal therapy for uterine sarcoma
- Concurrent hormone replacement therapy allowed
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy for uterine sarcoma and recovered
- No prior radiotherapy to more than 25% of marrow-bearing areas
- See Disease Characteristics
- Recovered from prior surgery
- At least 3 weeks since any other prior therapy for uterine sarcoma
- No prior anticancer therapy that would preclude study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (thalidomide)
Patients receive oral thalidomide once daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS) > 6 Months
Time Frame: Every other cycle for 6 months
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Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
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Every other cycle for 6 months
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Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0
Time Frame: Each cycle during treatment and 30 days after the last treatment (average 4 months)
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Each cycle during treatment and 30 days after the last treatment (average 4 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: Every other cycle until progression or death, up to 5 years.
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Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
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Every other cycle until progression or death, up to 5 years.
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Tumor Response
Time Frame: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. (average = 4 months)
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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.
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For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. (average = 4 months)
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Overall Survival
Time Frame: From study entry to death or last contact, up to 5 years.
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The observed length of life from entry into the study to death or the date of last contact.
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From study entry to death or last contact, up to 5 years.
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Initial Performance Status
Time Frame: baseline
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Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction. Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work. Performance status 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. |
baseline
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Initial Histologic Grade
Time Frame: Baseline
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G3 - Predominantly solid or entirely undifferentiated carcinoma.
Not graded - tumor grade not reported.
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Baseline
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum and Plasma Concentrations of VEGF and bFGF With PFS
Time Frame: Up to 5 years
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Up to 5 years
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Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF
Time Frame: Up to 5 years
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Up to 5 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: D. McMeekin, Gynecologic Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Disease Attributes
- Neoplasms, Complex and Mixed
- Sarcoma
- Recurrence
- Carcinosarcoma
- Mixed Tumor, Mullerian
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
Other Study ID Numbers
- NCI-2012-02421 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA027469 (U.S. NIH Grant/Contract)
- CDR0000068967
- GOG-0230B (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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