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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
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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
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. maximum tolerated doses of drugs in combination
  2. overall toxicity of drug combination
  3. preliminary antitumor activity of drug combination
  4. impact of pemetrexed on topotecan pharmacokinetics

Eligibility Criteria
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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
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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
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United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
GlaxoSmithKline
Eli Lilly and Company
Investigators
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Principal Investigator: Howard Burris, MD SCRI Development Innovations, LLC
More Information
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ClinicalTrials.gov Identifier: NCT00315861    
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:
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Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases
Pemetrexed
 Topotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors