Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer

NCT00322751 | Completed Phase 1 DMC

• 1 other identifier: INST 0529C
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Given the activity of single-agent Topotecan in NSCLC, there is both scientific rationale and a medical interest in studying this agent in combination with radiation. In addition, Topotecan administered on a weekly basis offers advantages over the daily x 5 regimen, i.e., the convenience of administration and fewer visits to the clinic.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT

  Treatment with topotecan will last until RT is completed. Treatment will stop if there is disease progression or unacceptable toxicity

Interventions

Topotecan DRUG

The starting dose for the first cohort will be 2 mg/m2/week. Increment between cohorts will be by 1 mg/m2/week if no toxicity related to topotecan occurs. All members of a dose cohort must have safely completed all radiotherapy and topotecan dosing prior to beginning enrollment in the next higher dose cohort. Increments will be reduced to 0.5 mg/m2 if mild to moderate toxicity occurs (grades 1 or 2). The escalation will continue until the maximum dose of 4 mg/m2/week is reached. Therefore the minimum number of dose levels (cohorts) is 3 to reach the goal of 4 mg/m2/week, and the maximum is 5.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically proven non-small cell lung cancer Stage I to IIIA.
• Inoperable lung cancer because of poor respiratory lung function, or other medical reasons, as determined by the thoracic surgeon.
• PS \< 2
• Age \> 18 years
• Life expectancy of \> 12 weeks
• Normal hematologic, liver, and renal function
• No metastatic disease as determined by CT-PET scanning and bone scan.
• No brain metastasis by MRI
• No contraindication to radiotherapy

You may not qualify if:

• Patients with uncontrolled CNS metastases.
• Active systemic infection.
• Serious, uncontrolled intercurrent medical or psychiatric illness.
• Secondary active primary malignancy.
• Inability to comply with requirements of the study.
• Any metastases outside of the mediastinum
• Histologically positive pleural or pericardial effusion
• Any chemotherapy within five years prior to enrollment on this protocol
• Prior radiotherapy administered to the chest
• Women who are pregnant or lactating
• FEV1 \< 1 liter/minute

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Dennie Jones, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 8, 2006
• Study Start: April 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 7, 2010

Record last verified: 2009-11

Locations

US (1)