Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer

A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00116610

Enrollment

Registered

2005-06-30

Start date

2005-06-30

Completion date

2008-03-31

Last updated

2009-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer, resistant, refractory, platinum, chemotherapy, second-line, relapse, sensitive

Brief summary

This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles.

Detailed description

Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.

Interventions

DRUGpicoplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Main inclusion criteria: 1. Diagnosis of small cell lung cancer. 2. Patients must have had one prior chemotherapy regimen which must have included either cisplatin or carboplatin. \[Additional eligibility criteria apply.\]

Exclusion criteria

* Prior radiotherapy that included \> 30% of the bone marrow (i.e., the whole of the pelvis or half of the spine). * Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom. * Significant heart disease. * Uncontrolled, untreated, unstable, or symptomatic brain tumors or central nervous system disease. * Grade 2+ peripheral neuropathy (a condition caused by damage to the nerves in the peripheral nervous system). \[Additional

Design outcomes

Primary

Measure	Time frame
Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)	—

Countries

Canada, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026