Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
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ClinicalTrials.gov Identifier: NCT00315861 |
Recruitment Status :
Completed
First Posted : April 19, 2006
Last Update Posted : January 23, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer Endometrial Cancer Cervical Cancer Lung Cancer | Drug: pemetrexed Drug: topotecan | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | January 2009 |

- maximum tolerated doses of drugs in combination
- overall toxicity of drug combination
- preliminary antitumor activity of drug combination
- impact of pemetrexed on topotecan pharmacokinetics

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315861
United States, Tennessee | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37023 |
Principal Investigator: | Howard Burris, MD | SCRI Development Innovations, LLC |
ClinicalTrials.gov Identifier: | NCT00315861 |
Other Study ID Numbers: |
SCRI REFMAL 72 105114 H3E-US-I013 LILLY |
First Posted: | April 19, 2006 Key Record Dates |
Last Update Posted: | January 23, 2009 |
Last Verified: | January 2009 |
ovarian carcinoma endometrial carcinoma cervical carcinoma lung carcinoma |
Endometrial Neoplasms Neoplasms Neoplasms by Site Genital Neoplasms, Female Urogenital Neoplasms Uterine Neoplasms Uterine Diseases Pemetrexed |
Topotecan Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Topoisomerase I Inhibitors Topoisomerase Inhibitors |