ZD0473 in Treating Patients With Progressive or Relapsed Non-Small Lung Cancer

NCT00021008 | Unknown Phase 2

• 4 other identifiers: CDR0000068738UCLA-000307201AZENECA-0473IL/0003NCI-G01-1974
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ZD0473 in treating patients who have progressive or relapsed non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

picoplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Progressive or relapsed disease after first-line platinum-based chemotherapy Measurable disease No intracerebral metastases (unless asymptomatic, no corticosteroids required, and diagnostic imaging demonstrates no peritumoral edema or progression) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.25 times the upper limit of normal (ULN) ALT or AST less than 2.5 times ULN (5 times ULN if liver metastases present) No hepatic impairment No risk of hepatitis B transmission Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No currently unstable or uncompensated cardiac conditions Pulmonary: No currently unstable or uncompensated respiratory conditions Other: No risk of HIV transmission No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix No other severe or uncontrolled systemic disease No infectious condition No significant clinical disorder that would preclude study Body surface area at least 1.2 m2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception for 3 months before, during, and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: No prior extensive radiotherapy to 30% or more of bone marrow (e.g., whole of pelvis or half of spine) Surgery: Recovered from prior surgery Other: At least 2 weeks since prior systemic anticancer therapy and recovered

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

amminedichloro(2-methylpyridine)platinum(II)

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Robert A. Figlin, MD, FACP

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: April 13, 2004
• Last Updated: December 19, 2013

Record last verified: 2001-09