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Open Label Study of Single Dose Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy


Phase 1
21 Years
N/A
Not Enrolling
Both
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Neoplasm Recurrence, Local

Thank you

Trial Information

Open Label Study of Single Dose Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy


We want to learn more about the side effect profile of both Technetium Tc 99m P2045 and
Rhenium Re 188 P2045 and will do that by observing you closely after you receive the drug
and by conducting multiple tests, as well as by asking you how you feel. We want to also
learn if there is any benefit, in terms of lung cancer tumor reduction, as a result of
treatment with Rhenium Re 188 P2045.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer
HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of Rhenium 188 P2045

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

91168

NCT ID:

NCT00100256

Start Date:

January 2004

Completion Date:

April 2005

Related Keywords:

  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Small Cell
  • Neoplasm Recurrence, Local
  • Advanced or recurrent stage IIIb or IV non small cell lung cancer
  • Disseminated or recurrent small cell lung cancer
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Recurrence, Local
  • Recurrence
  • Carcinoma, Small Cell

Name

Location
Bettendorf, Iowa  52722
Baltimore, Maryland  21287