Cervical CancerPhase 1NCT00842452
Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery
A Phase 1 study testing topotecan hydrochloride and pharmacological study in people with Cervical Cancer and Endometrial Cancer, run by Steven Waggoner, MD at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer
- What is being tested?
- topotecan hydrochloride and pharmacological study
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Apr 2011
- Phase
- Phase 1
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically* or cytologically confirmed unresectable gynecologic malignancy for which standard curative or palliative care is not available
- All tumor types allowed NOTE: *Histologic confirmation of recurrence is not required
- Measurable or nonmeasurable disease
- If CT scan was used to evaluate measurable disease, lesions must be clearly defined and be ≥ 10 mm on spiral CT scan
- No "borderline tumors" or tumors with low malignant potential
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 9 g/dL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Creatinine clearance ≥ 60 mL/min
- AST/ALT ≤ 2.5 times ULN (< 5 times ULN if liver metastases are present)
- Alkaline phosphatase ≤ 2.5 times ULN (< 5 times ULN if liver metastases are present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Adequate intestinal function (i.e., no gastrostomy tube or requirement for IV hydration or nutritional support)
- No severe gastrointestinal bleeding or intestinal obstruction
- No other condition that would affect gastrointestinal absorption and motility
- No septicemia, severe infection, or acute hepatitis
- No other malignancies requiring chemotherapy or radiotherapy within the past 5 years, except skin cancer
- No concurrent severe medical problem unrelated to the malignancy that would significantly limit full compliance with the study, expose the patient to extreme risk, or decrease life expectancy
PRIOR CONCURRENT THERAPY:
- At least 28 days since prior investigational drugs (including cytotoxic drugs)
- At least 4 weeks since prior chemotherapy, radiotherapy, biologic therapy, or surgery and recovered
- No more than 3 prior chemotherapy regimens
- No prior topotecan hydrochloride or other camptothecin analogs
- No prior radiotherapy to > 25% of the bone marrow
- No other concurrent chemotherapy, radiotherapy, biologic therapy, immunotherapy, or hormonal therapy for cancer
- No concurrent administration of any of the following:
- P-glycoprotein (ABCB1, Pgp, MDR1) inhibitors or inducers
- Breast cancer-resistant protein (ABCG2, BCRP, MXR) inhibitors or inducers
- No concurrent chronic H2 antagonists, proton pump inhibitors, or antacids for gastritis, gastroesophageal reflux disease, or gastric or duodenal ulcers
- Intermittent antacid therapy is allowed provided it is given ≥ 6 hours prior to and ≥ 90 minutes after study drug administration
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: A Phase I Study of Weekly Oral Topotecan in Gynecologic Malignancies
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with gynecologic cancer that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- To establish the maximum tolerated dose (MTD) of oral topotecan hydrochloride in patients with unresectable gynecologic malignancies.
- To determine the safety and tolerability of this drug in these patients.
- To obtain pharmacokinetic data to assess plasma concentrations of this drug when administered at the MTD.
Secondary
- To explore the response in patients treated with this drug.
OUTLINE: Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Vaginal Cancer
- Being tested
- topotecan hydrochloride, pharmacological study
- Keywords
- recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian germ cell tumor, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent vaginal cancer, stage III vaginal cancer, stage IVA vaginal cancer, stage IVB vaginal cancer, recurrent vulvar cancer, stage III vulvar cancer, stage IV vulvar cancer, recurrent cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Sarcoma, Vaginal Neoplasms, Vulvar Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecan hydrochlorideDrug
Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.
| Study group | Role | What they receive |
|---|---|---|
| Oral Topotecan | Experimental | Not described Receives: Drug: topotecan hydrochloride; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Safety and tolerability
Measured: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Plasma concentration of topotecan hydrochloride when administered at the MTD
Measured: blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies
Secondary outcomes (1)
Response
Measured: Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Waggoner, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Steven Waggoner, MD, Case Comprehensive Cancer Center
- Investigators
- Stephen Waggoner, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842452
- Sponsor's protocol ID
- CASE2Y08
- Other IDs
- P30CA043703, CASE2Y08, CASE 2Y08-CC630, NCI-2009-01290
- Status last verified
- Apr 2013
- First submitted
- 11 Feb 2009
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Weekly Oral Topotecan in Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT00842452
- Acronym / sponsor ID
- CASE2Y08
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Vaginal Cancer
- Keywords
- recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian germ cell tumor, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, recurrent endometrial carcinoma, stage III endometrial carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Steven Waggoner, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 Feb 2009 (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.
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with gynecologic cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- To establish the maximum tolerated dose (MTD) of oral topotecan hydrochloride in patients with unresectable gynecologic malignancies.
- To determine the safety and tolerability of this drug in these patients.
- To obtain pharmacokinetic data to assess plasma concentrations of this drug when administered at the MTD.
Secondary
- To explore the response in patients treated with this drug.
OUTLINE: Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Topotecan | Experimental | Drug: topotecan hydrochloride, Other: pharmacological study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| topotecan hydrochloridePatients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Drug | Oral Topotecan |
| pharmacological studyPatients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies. | Other | Oral Topotecan |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Safety and tolerability
Time frame: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Plasma concentration of topotecan hydrochloride when administered at the MTD
Time frame: blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies
1 secondary outcome
Response
Time frame: Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.
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 5 Apr 2013.
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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.
Stephen Waggoner, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive 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 1 study testing topotecan hydrochloride and pharmacological study in people with Cervical Cancer and Endometrial Cancer, run by Steven Waggoner, MD 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?
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 5 Apr 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum tolerated dose (MTD) (time frame: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.). The study lists 3 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 5 Apr 2013.