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Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
This study has been completed.
Sponsor:
SCRI Development Innovations, LLC
Collaborators:
GlaxoSmithKline
Eli Lilly and Company
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00315861
First received: April 17, 2006
Last updated: January 22, 2009
Last verified: January 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Ovarian Cancer Endometrial Cancer Cervical Cancer Lung Cancer | Drug: pemetrexed Drug: topotecan | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies |
Resource links provided by NLM:
Further study details as provided by SCRI Development Innovations, LLC:
Primary Outcome Measures:
- maximum tolerated doses of drugs in combination
- overall toxicity of drug combination
- preliminary antitumor activity of drug combination
- impact of pemetrexed on topotecan pharmacokinetics
| Estimated Enrollment: | 15 |
| Study Start Date: | March 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315861
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315861
Locations
| United States, Tennessee | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
Sponsors and Collaborators
SCRI Development Innovations, LLC
GlaxoSmithKline
Eli Lilly and Company
Investigators
| Principal Investigator: | Howard Burris, MD | SCRI Development Innovations, LLC |
More Information
| ClinicalTrials.gov Identifier: | NCT00315861 History of Changes |
| Other Study ID Numbers: |
SCRI REFMAL 72 105114 H3E-US-I013 LILLY |
| Study First Received: | April 17, 2006 |
| Last Updated: | January 22, 2009 |
Keywords provided by SCRI Development Innovations, LLC:
|
ovarian carcinoma endometrial carcinoma cervical carcinoma lung carcinoma |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
Pemetrexed Topotecan Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Topoisomerase I Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on June 26, 2017