Clinical trial NCT00100256: Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell
Neoplasm Recurrence, Local
Keywords: Advanced or recurrent stage IIIb or IV non small cell lung cancer
Disseminated or recurrent small cell lung cancer
Lead sponsor: Andarix Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum tolerated dose of Rhenium 188 P2045
timeFrame: Over the first month post dose administration
measure: Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045
timeFrame: Up to one year post study completion
measure: Progression free survival in treated patients
timeFrame: Up to one year post study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
Study officials:
affiliation: Andarix Pharmaceuticals
name: Andarix Study Director
role: STUDY_DIRECTOR
References: