Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent of Persistent Endometrial Carcinoma

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

Study Overview

• Status: Completed
• Conditions: Recurrent Endometrial Carcinoma; Endometrial Adenocarcinoma; Endometrial Clear Cell Carcinoma; Endometrial Papillary Serous Carcinoma; Endometrial Adenosquamous Cell Carcinoma; Endometrial Adenoacanthoma
• Intervention / Treatment: Other: laboratory biomarker analysis; Drug: thalidomide

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Gynecologic Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.	Other: laboratory biomarker analysis; Correlative studies; Drug: thalidomide; Given orally; Other Names: Kevadon; Synovir; THAL; Thalomid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients alive and progression-free	6 months
Frequency of adverse events assessed by CTC	Up to 6 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	From study entry until disease progression, death, or date of last contact, assessed up to 6 years
Overall survival	From entry into the study to death or the date of last contact, assessed up to 6 years
Frequency of clinical response using the GOG RECIST criteria	Up to 6 years

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: D. Scott McMeekin, Gynecologic Oncology Group

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: October 11, 2001
• First Submitted That Met QC Criteria: October 14, 2003
• First Posted (Estimate): October 15, 2003

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Disease Attributes; Neoplasms, Complex and Mixed; Cystadenocarcinoma; Neoplasms, Cystic, Mucinous, and Serous; Carcinoma; Recurrence; Endometrial Neoplasms; Cystadenocarcinoma, Serous; Adenocarcinoma, Clear Cell; Adenomyoepithelioma; Carcinoma, Adenosquamous; 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-2012-02420; U10CA027469 (U.S. NIH Grant/Contract); GOG-0229-B; CDR0000068964 (Registry Identifier: PDQ (Physician Data Query))