Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025467
First received: October 11, 2001
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent endometrial cancer. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor


Condition Intervention Phase
Endometrial Adenoacanthoma
Endometrial Adenocarcinoma
Endometrial Adenosquamous Cell Carcinoma
Endometrial Clear Cell Carcinoma
Endometrial Papillary Serous Carcinoma
Recurrent Endometrial Carcinoma
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 of Persistent Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of patients alive and progression-free [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency of adverse events assessed by CTC [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From study entry until disease progression, death, or date of last contact, assessed up to 6 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 6 years ] [ Designated as safety issue: No ]
  • Frequency of clinical response using the GOG RECIST criteria [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2001
Primary Completion Date: July 2007 (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:

I. Determine the antitumor cytostatic activity of thalidomide, in terms of 6-month progression-free survival, in patients with recurrent or persistent endometrial carcinoma.

II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the partial and complete response rates in patients treated with this drug.

IV. Determine the duration of progression-free and overall survival in patients treated with this drug.

V. Determine the effect of this drug on initial performance status and histological grade in these patients.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed endometrial carcinoma

    • Recurrent or persistent (refractory to curative therapy or established treatment)
    • No sarcomas
  • At least 1 unidimensionally measurable 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
  • At least 1 target lesion outside the area of prior radiotherapy
  • Received 1 prior chemotherapy regimen for endometrial carcinoma

    • Initial treatment may include high-dose therapy, consolidation, or extended therapy
    • No more than 1 additional cytotoxic regimen for recurrent or persistent disease
    • No non-cytotoxic chemotherapy for recurrent or persistent disease
  • Ineligible for higher priority GOG protocols (any active GOG phase III protocol for the same patient population)
  • No documented brain metastases since diagnosis of cancer

    • Patients with stable CNS deficits allowed provided there are no brain metastases, as confirmed by CT scan or MRI
  • Performance status - GOG 0-2 if patient received 1 prior regimen
  • Performance status - GOG 0-1 if patient received 2 prior 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 2 methods of effective contraception for 4 weeks before, during, and for 4 weeks after study participation
  • No active infection requiring antibiotics
  • No sensory or motor neuropathy greater than grade 1
  • No other invasive malignancy within the past 5 years except non-melanoma skin cancer
  • No documented seizure disorders since diagnosis of cancer

    • Patients with a history of seizure disorders allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen
  • At least 3 weeks since prior biologic or immunologic agents directed at malignancy
  • No prior thalidomide
  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy directed at malignancy and recovered
  • At least 1 week since prior hormonal therapy directed at malignancy
  • Concurrent hormone replacement therapy allowed
  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy directed at malignancy and recovered
  • No prior radiotherapy to more than 25% of marrow-bearing areas
  • Recovered from prior surgery
  • At least 3 weeks since any other prior therapy directed at malignancy
  • No prior cancer therapy that would preclude study participation
  • No concurrent bisphosphonates (e.g., zoledronate)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025467

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: NCT00025467     History of Changes
Other Study ID Numbers: NCI-2012-02420, GOG-0229-B, U10CA027469, CDR0000068964
Study First Received: October 11, 2001
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Adenosquamous
Adenocarcinoma, Clear Cell
Adenomyoepithelioma
Cystadenocarcinoma, Serous
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Uterine Neoplasms
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

ClinicalTrials.gov processed this record on April 17, 2014