Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025506
First received: October 11, 2001
Last updated: May 20, 2014
Last verified: December 2013
  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 ]

Enrollment: 51
Study Start Date: September 2001
Study Completion Date: January 2013
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:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, NCI-2012-02421, CDR0000068967, GOG-0230B, GOG-0230B, U10CA027469
Study First Received: October 11, 2001
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinosarcoma
Mixed Tumor, Mullerian
Uterine Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Sarcoma
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 September 16, 2014