Trial Condition(s):

Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Neoplasm Recurrence, Local

Rhenium Re 188 P2045 in Patients with Lung Cancer who have Received or Refused to Receive Prior Chemotherapy

Bayer Identifier:

91168

ClinicalTrials.gov Identifier:

NCT00100256

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to determine the maximum dose that is safely tolerated of the experimental drug Rhenium Re 188 P2045. This will be done by first treating patients at relatively low doses of Rhenium Re 188 P2045, observing them closely to assure that there are no bad side effects, then increasing the dose when we are confident that it is safe to do so.

Inclusion Criteria
:
 - Has histologically or cytologically documented Non-Small-Cell Lung Cancer (NSCLC) or Small-Cell Lung Cancer (SCLC) and has advanced or recurrent IIIb or IV NSCLC (adenocarcinoma, squamous cell carcinoma, large cell, mixed or not otherwise specified) or disseminated or recurrent SCLC or any lung cancer which has local recurrence.
 - Has documentation of progressive disease following prior chemotherapy or who refused to receive standard chemotherapy.
 - Has measurable tumor (at least 1 cm unidimensionally) in a previously non-irradiated area or, if in previously irradiated area, a substantial increase in size of tumor, based on CT scan within 8 weeks prior to enrollment; tumor in previously irradiated area only if it has increased by 50% or more from previous minimal diameter AND it is more than 8 weeks from the radiation.
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
19
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Rhenium (Re 188 P2045, BAY86-5284)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Baltimore, United States, 21201

Status
Completed
 
Locations

Investigative Site

Iowa City, United States, 52242

Status
Recruiting
 
Locations

Investigative Site

Iowa City, United States, 52246

Status
Not yet recruiting
 

Trial Design