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

Sponsor:

Collaborators:

GlaxoSmithKline

Eli Lilly and Company

Information provided by:

SCRI Development Innovations, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer Endometrial Cancer Cervical Cancer Lung Cancer	Drug: pemetrexed Drug: topotecan	Phase 1

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


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Lung cancer Ovarian cancer

Drug Information available for: Topotecan hydrochloride Topotecan Pemetrexed Pemetrexed disodium

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

Information from the National Library of Medicine

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

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
First Posted:	April 19, 2006 Key Record Dates
Last Update Posted:	January 23, 2009
Last Verified:	January 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

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