Brief Title
Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
Official Title
A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
Brief 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 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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
maximum tolerated doses of drugs in combination
Condition
Ovarian Cancer
Intervention
pemetrexed
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
15
Start Date
March 2006
Completion Date
January 2009
Primary Completion Date
May 2008
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Howard Burris, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00315861
Organization ID
SCRI REFMAL 72
Secondary IDs
105114
Study Sponsor
SCRI Development Innovations, LLC
Collaborators
GlaxoSmithKline
Study Sponsor
Howard Burris, MD, Principal Investigator, SCRI Development Innovations, LLC
Verification Date
January 2009