Ovarian CancerPhase 2NCT00634894
Femara (Letrozole) Versus Placebo for Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study testing Femara in people with Ovarian Cancer and Fallopian Tube Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. Evaluate the efficacy of letrozole to increase the duration of progression-free survival (defined as time to earliest occurrence of local or distant recurrence or clinically significant elevation in CA-125) when used as adjuvant treatment after completion of primary surgery and first line… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Femara
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2008
- 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
- Patients with optimally debulked (< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal cancer that have achieved a complete clinical response (CR) to first-line surgery and chemotherapy.
- All patients must have had appropriate surgery with appropriate tissue available for histologic evaluation to confirm diagnosis and stage.
- Patients must have completed primary treatment within the past 8 weeks and received at least 5 cycles and not more than 8 cycles of a platinum (IV or IP) and paclitaxel or docetaxel-based combination chemotherapy. Patients must have no symptoms suggestive of persistent cancer.
- Patient must have a CT or MRI scan of the abdomen/pelvis with no evidence of metastatic disease and a normal CA-125 (< 35 Units/mL) following primary therapy.
- Patients willing to sign informed consent to participate in study for 5 years or until first recurrence.
Who cannot join
- Patients with any evidence of metastatic disease after completion of surgery and first line chemotherapy
- Patients with low grade ovarian cancer histology.
- If chemotherapy initiated greater than 8 weeks after primary surgery or completed more than 8 weeks prior to treatment start.
- Patients that received neoadjuvant chemotherapy.
- Patients taking any form of HRT and/or CAM products (i.e. phytoestrogens, etc.)
- Patients with history of prothrombic clotting disorders (i.e PE or DVT).
- Patients with history of malignant disease within past 10 years except for squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
- Patients with severe concomitant disease which would place patient at unusual risk or confound the results of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Double-Blinded, Randomized Evaluation of Femara (Letrozole) Versus Placebo for Adjuvant Treatment After Completion of First-Line Chemotherapy for Patients With Optimally Debulked and Chemoresponsive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Primary Objective:
- Evaluate the efficacy of letrozole to increase the duration of progression-free survival (defined as time to earliest occurrence of local or distant recurrence or clinically significant elevation in CA-125) when used as adjuvant treatment after completion of primary surgery and first line platinum containing chemotherapy in patients with optimally debulked (< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal cancer.
Secondary Objective:
- Observe the incidence of local and distant recurrences.
Read the detailed description
THE STUDY DRUG:
Letrozole is designed to block the enzyme that makes estrogen in post-menopausal women. By interfering with the production of estrogen made by the enzyme, letrozole decreases the total amount of estrogen in the body. As a result, less estrogen can reach cancer cells, which may prevent their growth.
SCREENING TESTS:
Before you can begin taking the study drug on this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam, including a pelvic exam and measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Blood (about 2-3 teaspoons) will be drawn for routine tests and to test for tumor markers.
- You will have a chest x-ray and a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan to check the status of the disease.
- Your previously collected tumor tissue, if available, will be tested to learn if the estrogen receptor is positive or negative.
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
STUDY GROUPS:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take letrozole. Group 2 will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients. Neither the doctor nor you will know which group you will be in. However, if needed for your safety, the study staff and study doctor will be able to find out which group you are in.
STUDY DRUG ADMINISTRATION:
You will take letrozole or the placebo by mouth 1 time every day of each 12-week study "cycle". It should be taken around the same time every day and can be taken with or without food and/or water. You will be given the amount of study drug/placebo needed for 1 cycle of therapy at a time.
You will keep a drug "diary" during the study. In this diary you will list when and how much study drug/placebo you took. This diary will be reviewed after each cycle.
STUDY VISITS:
Within 4 weeks before your first dose of study drug/placebo, you will have a bone scan to test your bones and to watch for any signs of osteoporosis (weakened bones) that can be caused by decreased estrogen levels. You will be separately consented for this bone scan, which will describe the procedure and its risks in detail.
Every 12 weeks, the following tests and procedures will be performed:
- Blood (about 2-3 teaspoons) will be drawn for routine tests and to test for tumor markers.
- You will have a CT scan of the chest, abdomen, and pelvis to check the status of the disease.
- You will have a physical exam, including a pelvic exam and measurement of your vital signs and weight.
- You will have a performance status evaluation.
- You will be asked if you have experienced any side effects.
Every 6 months, you will have a chest x-ray.
Every year, you will have a bone scan to check for osteoporosis.
LENGTH OF STUDY:
You may remain on the study for as long as you are not experiencing intolerable side effects and the disease has not gotten worse. In that case, you will be taken off study. The total length of the study is five (5) years. At the end of the study, if you are still on active treatment, you and your doctor may or may not decide to continue treatment off-study.
END-OF-STUDY VISIT:
On the last day that you take the study drug/placebo, you will have an end-of-study visit. The following tests and procedures will be performed:
- Blood (about 2-3 teaspoons) will be drawn for routine tests and to test for tumor markers.
- You will have a physical exam, including a pelvic exam and measurement of your vital signs and weight.
- You will have an MRI scan or CT scan to check the status of the disease.
- You will have a performance status evaluation.
- You will be asked if you have experienced any side effects.
This is an investigational study. Letrozole is commercially available and FDA approved for the treatment of some types of breast cancer. Its use in patients with ovarian cancer is experimental. While you are on study, letrozole or the placebo will be provided at no cost to you.
Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Being tested
- Femara, Placebo
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Femara, Letrozole, Placebo
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemaraDrug
Also called Letrozole
2.5 mg by mouth daily x 12 weeks
PlaceboDrug
Placebo capsule by mouth daily x 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Femara | Experimental | Not described Receives: Drug: Femara |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-free survival (PFS): Time to progression or death from complete response (CR)
PFS defined as time to earliest occurrence of local or distant recurrence or clinically significant elevation in CA-125. Biochemical progression is defined as two serially rising serum values of CA-125 greater than or equal to two times the upper limits of normal (ULN >35 U/ML) performed at least one week apart, regardless of CT scan results.
Measured: Assessed after 12 weeks of therapy, and followed for 36 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Study halted with no registration, the drug company sponsor withdrew support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Judith Wolf, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634894
- Sponsor's protocol ID
- 2006-0689
- Status last verified
- Sep 2009
- First submitted
- 6 Mar 2008
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blinded, Randomized Evaluation of Femara (Letrozole) Versus Placebo for Adjuvant Treatment After Completion of First-Line Chemotherapy for Patients With Optimally Debulked and Chemoresponsive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT00634894
- Acronym / sponsor ID
- 2006-0689
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Femara, Letrozole, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted with no registration, the drug company sponsor withdrew support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Mar 2008 (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.
Primary Objective:
- Evaluate the efficacy of letrozole to increase the duration of progression-free survival (defined as time to earliest occurrence of local or distant recurrence or clinically significant elevation in CA-125) when used as adjuvant treatment after completion of primary surgery and first line platinum containing chemotherapy in patients with optimally debulked (< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal cancer.
Secondary Objective:
- Observe the incidence of local and distant recurrences.
Detailed description
THE STUDY DRUG:
Letrozole is designed to block the enzyme that makes estrogen in post-menopausal women. By interfering with the production of estrogen made by the enzyme, letrozole decreases the total amount of estrogen in the body. As a result, less estrogen can reach cancer cells, which may prevent their growth.
SCREENING TESTS:
Before you can begin taking the study drug on this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam, including a pelvic exam and measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Blood (about 2-3 teaspoons) will be drawn for routine tests and to test for tumor markers.
- You will have a chest x-ray and a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan to check the status of the disease.
- Your previously collected tumor tissue, if available, will be tested to learn if the estrogen receptor is positive or negative.
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
STUDY GROUPS:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take letrozole. Group 2 will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients. Neither the doctor nor you will know which group you will be in. However, if needed for your safety, the study staff and study doctor will be able to find out which group you are in.
STUDY DRUG ADMINISTRATION:
You will take letrozole or the placebo by mouth 1 time every day of each 12-week study "cycle". It should be taken around the same time every day and can be taken with or without food and/or water. You will be given the amount of study drug/placebo needed for 1 cycle of therapy at a time.
You will keep a drug "diary" during the study. In this diary you will list when and how much study drug/placebo you took. This diary will be reviewed after each cycle.
STUDY VISITS:
Within 4 weeks before your first dose of study drug/placebo, you will have a bone scan to test your bones and to watch for any signs of osteoporosis (weakened bones) that can be caused by decreased estrogen levels. You will be separately consented for this bone scan, which will describe the procedure and its risks in detail.
Every 12 weeks, the following tests and procedures will be performed:
- Blood (about 2-3 teaspoons) will be drawn for routine tests and to test for tumor markers.
- You will have a CT scan of the chest, abdomen, and pelvis to check the status of the disease.
- You will have a physical exam, including a pelvic exam and measurement of your vital signs and weight.
- You will have a performance status evaluation.
- You will be asked if you have experienced any side effects.
Every 6 months, you will have a chest x-ray.
Every year, you will have a bone scan to check for osteoporosis.
LENGTH OF STUDY:
You may remain on the study for as long as you are not experiencing intolerable side effects and the disease has not gotten worse. In that case, you will be taken off study. The total length of the study is five (5) years. At the end of the study, if you are still on active treatment, you and your doctor may or may not decide to continue treatment off-study.
END-OF-STUDY VISIT:
On the last day that you take the study drug/placebo, you will have an end-of-study visit. The following tests and procedures will be performed:
- Blood (about 2-3 teaspoons) will be drawn for routine tests and to test for tumor markers.
- You will have a physical exam, including a pelvic exam and measurement of your vital signs and weight.
- You will have an MRI scan or CT scan to check the status of the disease.
- You will have a performance status evaluation.
- You will be asked if you have experienced any side effects.
This is an investigational study. Letrozole is commercially available and FDA approved for the treatment of some types of breast cancer. Its use in patients with ovarian cancer is experimental. While you are on study, letrozole or the placebo will be provided at no cost to you.
Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femara | Experimental | Drug: Femara |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with optimally debulked (< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal cancer that have achieved a complete clinical response (CR) to first-line surgery and chemotherapy.
- All patients must have had appropriate surgery with appropriate tissue available for histologic evaluation to confirm diagnosis and stage.
- Patients must have completed primary treatment within the past 8 weeks and received at least 5 cycles and not more than 8 cycles of a platinum (IV or IP) and paclitaxel or docetaxel-based combination chemotherapy. Patients must have no symptoms suggestive of persistent cancer.
- Patient must have a CT or MRI scan of the abdomen/pelvis with no evidence of metastatic disease and a normal CA-125 (< 35 Units/mL) following primary therapy.
- Patients willing to sign informed consent to participate in study for 5 years or until first recurrence.
Key exclusion criteria (8 listed)
- Patients with any evidence of metastatic disease after completion of surgery and first line chemotherapy
- Patients with low grade ovarian cancer histology.
- If chemotherapy initiated greater than 8 weeks after primary surgery or completed more than 8 weeks prior to treatment start.
- Patients that received neoadjuvant chemotherapy.
- Patients taking any form of HRT and/or CAM products (i.e. phytoestrogens, etc.)
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 |
|---|---|---|
| FemaraAlso: Letrozole2.5 mg by mouth daily x 12 weeks | Drug | Femara |
| PlaceboPlacebo capsule by mouth daily x 12 weeks | Drug | Placebo |
Primary outcome
Median Progression-free survival (PFS): Time to progression or death from complete response (CR)
Time frame: Assessed after 12 weeks of therapy, and followed for 36 months post-treatment
PFS defined as time to earliest occurrence of local or distant recurrence or clinically significant elevation in CA-125. Biochemical progression is defined as two serially rising serum values of CA-125 greater than or equal to two times the upper limits of normal (ULN >35 U/ML) performed at least one week apart, regardless of CT scan results.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Judith Wolf, MD principal investigator
UT MD Anderson Cancer Center
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 Femara in people with Ovarian Cancer and Fallopian Tube Cancer, run by M.D. Anderson Cancer Center 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 20 Apr 2016. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Median Progression-free survival (PFS): Time to progression or death from complete response (CR) (time frame: Assessed after 12 weeks of therapy, and followed for 36 months post-treatment). 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 20 Apr 2016.