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
  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:


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:
Ovarian Neoplasms
Uterine Cervical Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
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 October 20, 2014