Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy

Sponsor

Andarix Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00100256

Collaborator

(none)

Enrollment

Locations

Arm

195

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Neoplasm Recurrence, Local	Drug: Rhenium (Re 188 P2045, BAY86-5284)	Phase 1/Phase 2

Detailed Description

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. Andarix Pharmaceuticals is the sponsor of the trial.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2004

Primary Completion Date :

Jun 1, 2004

Anticipated Study Completion Date :

Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Rhenium (Re 188 P2045, BAY86-5284) Infusion once only

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Rhenium (Re 188 P2045, BAY86-5284)

Infusion once only

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose of Rhenium 188 P2045 [Over the first month post dose administration]
Toxicity as determined by the analysis protocol
Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045 [Up to one year post study completion]
Examination of clinical chemistry indicators as outlined in the protocol
Progression free survival in treated patients [Up to one year post study completion]
Analyze tumor and disease progression after dosing

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.