A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
18 Years
N/A
Both
Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer
Trial Information
A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
maximum tolerated doses of drugs in combination
Principal Investigator
Howard Burris, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
SCRI REFMAL 72
NCT ID:
NCT00315861
Start Date:
March 2006
Completion Date:
January 2009
Related Keywords:
- Ovarian Cancer
- Endometrial Cancer
- Cervical Cancer
- Lung Cancer
- ovarian carcinoma
- endometrial carcinoma
- cervical carcinoma
- lung carcinoma
- Endometrial Neoplasms
- Uterine Cervical Neoplasms
- Lung Neoplasms
- Ovarian Neoplasms
- Adenoma
Name | Location |
|---|---|
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
