Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies - Full Text View

Sponsors and Collaborators:	Sarah Cannon Research Institute SCRI Oncology Research Consortium GlaxoSmithKline Eli Lilly and Company
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00315861

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 I

MedlinePlus related topics: Cancer Lung Cancer Ovarian Cancer

Drug Information available for: Topotecan hydrochloride Topotecan Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies

Further study details as provided by Sarah Cannon Research Institute:

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

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

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

Sarah Cannon Research Institute

SCRI Oncology Research Consortium

GlaxoSmithKline

Eli Lilly and Company

Investigators

Principal Investigator:

Howard Burris, MD

Sarah Cannon Research Institute

More Information

Study ID Numbers:	SCRI REFMAL 72, 105114, H3E-US-I013 LILLY
Study First Received:	April 17, 2006
Last Updated:	October 15, 2007
ClinicalTrials.gov Identifier:	NCT00315861
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sarah Cannon Research Institute:

ovarian carcinoma
endometrial carcinoma
cervical carcinoma
lung carcinoma

Study placed in the following topic categories:

Thoracic Neoplasms
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Uterine Diseases
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Carcinoma
Folic Acid

Pemetrexed
Genital Diseases, Female
Endometrial Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Uterine Neoplasms
Endocrinopathy
Endometrial cancer
Topotecan
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009