Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025506
First received: October 11, 2001
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
This phase II trial is studying how well thalidomide works in treating patients with recurrent or persistent carcinosarcoma of the uterus. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Uterine Sarcoma Uterine Carcinosarcoma |
Drug: thalidomide Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Proportion of patients alive [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Frequency and severity of adverse effects as assessed by Common Toxicity Criteria (CTC) v2.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Frequency of clinical response as assessed by Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Duration of overall survival and PFS [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Initial performance status and histological grade [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Serum and plasma concentrations of vascular endothelial growth factor (VEGF) and bFGF [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Serum and plasma concentrations of VEGF and bFGF with PFS [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 51 |
| Study Start Date: | September 2001 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: thalidomide
Given orally
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025506
Locations
| United States, Pennsylvania | |
| Gynecologic Oncology Group | |
| Philadelphia, Pennsylvania, United States, 19103 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | D. Scott McMeekin | Gynecologic Oncology Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00025506 History of Changes |
| Other Study ID Numbers: | NCI-2012-02421, GOG-0230B, U10CA027469, CDR0000068967 |
| Study First Received: | October 11, 2001 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinosarcoma Mixed Tumor, Mullerian Uterine Neoplasms Sarcoma Neoplasms, Complex and Mixed Neoplasms by Histologic Type Neoplasms Neoplasms, Connective and Soft Tissue Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Thalidomide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013