Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00025467
Other study ID # NCI-2012-02420
Secondary ID GOG-0229-BU10CA0
Status Completed
Phase Phase 2
First received October 11, 2001
Last updated January 23, 2013
Start date September 2001

Study information

Verified date January 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
thalidomide
Given orally
Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States Gynecologic Oncology Group Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients alive and progression-free 6 months No
Primary Frequency of adverse events assessed by CTC Up to 6 years Yes
Secondary Progression-free survival From study entry until disease progression, death, or date of last contact, assessed up to 6 years No
Secondary Overall survival From entry into the study to death or the date of last contact, assessed up to 6 years No
Secondary Frequency of clinical response using the GOG RECIST criteria Up to 6 years No
See also
  Status Clinical Trial Phase
Completed NCT01935973 - Trametinib With or Without GSK2141795 in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 1
Active, not recruiting NCT03660826 - Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone Phase 2
Active, not recruiting NCT04106414 - Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment Phase 2
Completed NCT01642082 - Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT01208467 - Prognostic Biomarkers in Patients With Endometrial Cancer N/A
Completed NCT01011933 - Selumetinib in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT01440998 - Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer Phase 1
Completed NCT00006089 - Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Phase 2
Active, not recruiting NCT00977574 - Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Phase 2
Recruiting NCT05001282 - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±) Phase 1/Phase 2
Completed NCT01968317 - Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma Phase 2
Completed NCT01225887 - Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT01005329 - Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer Phase 2
Active, not recruiting NCT02208375 - mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Phase 1/Phase 2
Completed NCT03716414 - Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
Withdrawn NCT03836157 - Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer Phase 2
Not yet recruiting NCT06399757 - A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT00095979 - Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT00072176 - Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer Phase 2
Active, not recruiting NCT03460483 - Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care N/A