Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies

This study has been completed.

Sponsor:

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

History of Changes

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 Endpoint Classification: Safety Study 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:

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

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)

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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided


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
Health Authority:	United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:


ovarian carcinoma endometrial carcinoma cervical carcinoma lung carcinoma

Additional relevant MeSH terms:


Pemetrexed Topotecan Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors	Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Topoisomerase I Inhibitors Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on March 03, 2015

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