Ovarian CancerPhase 1NCT00315861
Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
A Phase 1 study testing pemetrexed and topotecan in people with Ovarian Cancer and Endometrial Cancer, run by SCRI Development Innovations, LLC at 1 site in United States.
Trial summary
Currently, no data exists regarding the safety and tolerability of a combination regimen utilizing weekly topotecan in combination with pemetrexed. Although both drugs are associated with myelosuppression, it is hoped that the utilization of the weekly topotecan dosing schedule will allow the drugs to be easily… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer
- What is being tested?
- pemetrexed and topotecan
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jan 2009
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven advanced solid tumors
- Measurable or evaluable disease
- Age ≥ 18 years
- Karnofsky performance status ≥ 80% (ECOG 0 or 1)
- Adequate liver, bone marrow and kidney function
Who cannot join
- More than 3 prior chemotherapy regimens in the metastatic setting
- Prior treatment with topotecan or pemetrexed
- Clinically significant third space fluid present at the time of treatment
- Unable to interrupt aspirin, other non-steroidal anti-inflammatory drugs
- Inability to take steroid premedications or vitamin supplementation
- The presence of active brain metastases
Show all 9Show fewer
- Prior radiotherapy within 4 weeks prior to the first day of treatment
- Prior surgery within 3 weeks prior to the first day of treatment
- Prior chemotherapy within 3 weeks prior to the first day of treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
About this study
Official title: A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
Currently, no data exists regarding the safety and tolerability of a combination regimen utilizing weekly topotecan in combination with pemetrexed. Although both drugs are associated with myelosuppression, it is hoped that the utilization of the weekly topotecan dosing schedule will allow the drugs to be easily combined. This phase I trial will evaluate the safety and tolerability of weekly topotecan in combination with pemetrexed in patients with advanced solid tumors.
Read the detailed description
Three patients will be accrued at each of 5 dose levels. Dose escalation will only proceed if none of the additional 3 patients experience DLT. The highest dose level that generates DLT in 0/3 or 1/6 patients will be the maximum tolerated dose (MTD) or the doses recommended for subsequent studies. A total of 10 patients will be treated at the MTD to further assess the toxicity of the dosing regimen and its suitability for use in subsequent trials. Patients may continue to receive treatment until unacceptable toxicity or disease progression is encountered. Treatment cycles will be repeated every 21 days. The protocol is also designed to enroll an additional 10 patients at the maximum tolerated dose to increase the confidence in the safety and suitability of the doses that are chosen for subsequent studies.
- Topotecan Day 1 and 8
- Pemetrexed Day 1
- Conditions
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer
- Being tested
- pemetrexed, topotecan
- Keywords
- ovarian carcinoma, endometrial carcinoma, cervical carcinoma, lung carcinoma
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
topotecanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated doses of drugs in combination
overall toxicity of drug combination
preliminary antitumor activity of drug combination
impact of pemetrexed on topotecan pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2008
- Study completionJan 2009
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Eli Lilly and Company
- Investigators
- Howard Burris, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315861
- Sponsor's protocol ID
- SCRI REFMAL 72
- Other IDs
- 105114, H3E-US-I013 LILLY
- Status last verified
- Jan 2009
- First submitted
- 17 Apr 2006
- Last updated
- 23 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00315861
- Acronym / sponsor ID
- SCRI REFMAL 72
- Conditions
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer
- Keywords
- ovarian carcinoma, endometrial carcinoma, cervical carcinoma, lung carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Eli Lilly and Company
- Study start
- Mar 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Apr 2006 (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.
Currently, no data exists regarding the safety and tolerability of a combination regimen utilizing weekly topotecan in combination with pemetrexed. Although both drugs are associated with myelosuppression, it is hoped that the utilization of the weekly topotecan dosing schedule will allow the drugs to be easily combined. This phase I trial will evaluate the safety and tolerability of weekly topotecan in combination with pemetrexed in patients with advanced solid tumors.
Detailed description
Three patients will be accrued at each of 5 dose levels. Dose escalation will only proceed if none of the additional 3 patients experience DLT. The highest dose level that generates DLT in 0/3 or 1/6 patients will be the maximum tolerated dose (MTD) or the doses recommended for subsequent studies. A total of 10 patients will be treated at the MTD to further assess the toxicity of the dosing regimen and its suitability for use in subsequent trials. Patients may continue to receive treatment until unacceptable toxicity or disease progression is encountered. Treatment cycles will be repeated every 21 days. The protocol is also designed to enroll an additional 10 patients at the maximum tolerated dose to increase the confidence in the safety and suitability of the doses that are chosen for subsequent studies.
- Topotecan Day 1 and 8
- Pemetrexed Day 1
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven advanced solid tumors
- Measurable or evaluable disease
- Age ≥ 18 years
- Karnofsky performance status ≥ 80% (ECOG 0 or 1)
- Adequate liver, bone marrow and kidney function
Key exclusion criteria (9 listed)
- More than 3 prior chemotherapy regimens in the metastatic setting
- Prior treatment with topotecan or pemetrexed
- Clinically significant third space fluid present at the time of treatment
- Unable to interrupt aspirin, other non-steroidal anti-inflammatory drugs
- Inability to take steroid premedications or vitamin supplementation
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 |
|---|---|---|
| pemetrexed | Drug | – |
| topotecan | Drug | – |
Primary outcome
maximum tolerated doses of drugs in combination
overall toxicity of drug combination
preliminary antitumor activity of drug combination
impact of pemetrexed on topotecan pharmacokinetics
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 23 Jan 2009.
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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.
Howard Burris, MD principal investigator
SCRI Development Innovations, LLC
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 pemetrexed and topotecan in people with Ovarian Cancer and Endometrial Cancer, run by SCRI Development Innovations, LLC 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 9 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 23 Jan 2009. 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 doses of drugs in combination. The study lists 4 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 23 Jan 2009; AzTrials last refreshed its copy on 7 Nov 2026.