Endometrial AdenoacanthomaPhase 2NCT00025467
Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
A Phase 2 study testing thalidomide and laboratory biomarker analysis in people with Endometrial Adenoacanthoma and Endometrial Adenocarcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Adenoacanthoma, Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma
- What is being tested?
- thalidomide and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 44Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: 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
Read the detailed description
OBJECTIVES:
- 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.
- 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.
- Conditions
- Endometrial Adenoacanthoma, Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Recurrent Endometrial Carcinoma
- Being tested
- thalidomide, laboratory biomarker analysis
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomideDrug
Also called Kevadon, Synovir, THAL, Thalomid
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (thalidomide) | Experimental | Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: thalidomide; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients alive and progression-free
Measured: 6 months
Frequency of adverse events assessed by CTC
Measured: Up to 6 years
Secondary outcomes (3)
Progression-free survival
Measured: From study entry until disease progression, death, or date of last contact, assessed up to 6 years
Overall survival
Measured: 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
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2003 (estimated)
- Study startSep 2001
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial AdenoacanthomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- D. Scott McMeekin, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025467
- Sponsor's protocol ID
- NCI-2012-02420
- Other IDs
- GOG-0229-B, U10CA027469, CDR0000068964
- Status last verified
- Jan 2013
- First submitted
- 11 Oct 2001
- Last updated
- 24 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent of Persistent Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00025467
- Acronym / sponsor ID
- NCI-2012-02420
- Conditions
- Endometrial Adenoacanthoma, Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Recurrent Endometrial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2001
- Primary completion
- Jul 2007 (actual)
- First posted
- 15 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
OBJECTIVES:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (thalidomide) | Experimental | Drug: thalidomide, Other: laboratory biomarker analysisPatients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (44 listed)
- Histologically confirmed endometrial carcinoma
- At least 1 unidimensionally measurable lesion
- At least 1 target lesion outside the area of prior radiotherapy
- Received 1 prior chemotherapy regimen for endometrial carcinoma
- Ineligible for higher priority GOG protocols (any active GOG phase III protocol for the same patient population)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thalidomideAlso: Kevadon, Synovir, THAL, ThalomidGiven orally | Drug | Treatment (thalidomide) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (thalidomide) |
Primary outcome
Proportion of patients alive and progression-free
Time frame: 6 months
Frequency of adverse events assessed by CTC
Time frame: Up to 6 years
3 secondary outcomes
Progression-free survival
Time frame: From study entry until disease progression, death, or date of last contact, assessed up to 6 years
Overall survival
Time frame: 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
Time frame: Up to 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. Scott McMeekin principal investigator
Gynecologic Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing thalidomide and laboratory biomarker analysis in people with Endometrial Adenoacanthoma and Endometrial Adenocarcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 44 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients alive and progression-free (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.