Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT ID: NCT00061854

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2005-05-31

Brief Summary

RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have progressive locally advanced or metastatic non-small cell lung cancer.

Detailed Description

OBJECTIVES:

• Determine the objective tumor response rate and duration of response in patients with progressive locally advanced or metastatic non-small cell lung cancer treated with soblidotin as second-line therapy after receiving prior platinum-based chemotherapy.
• Determine the time to tumor progression in patients treated with this drug.
• Determine the median survival time and 12-month survival rate of patients treated with this drug.
• Determine the quantitative and qualitative toxic effects of this drug in these patients.
• Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Plasma sampling for pharmacokinetics is done on day 1 of course 1.

Patients are followed for survival every 3 months after discontinuing study treatment.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

soblidotin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

• Locally advanced or metastatic disease
• Demonstrates tumor progression
• Must have received 1 prior chemotherapy regimen

• Prior chemotherapy must have included a platinum agent
• Measurable disease

• At least 1 measurable lesion outside the field of any prior radiotherapy
• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

• Creatinine no greater than 1.5 times ULN

Cardiac

• Ejection fraction at least 40% by MUGA

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No psychiatric disorder that would preclude giving informed consent or following study instruction
• No grade 2 or greater neurotoxicity
• No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off therapy for that disease for at least 5 years prior to study entry
• No other concurrent severe or uncontrolled underlying medical disease that would compromise patient safety and study outcome
• No concurrent serious infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent anticancer biologic therapy

Chemotherapy

• See Disease Characteristics
• Recovered from prior chemotherapy
• No other concurrent anticancer chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• Recovered from prior radiotherapy
• No concurrent anticancer radiotherapy

• Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective

Surgery

• At least 4 weeks since prior major surgery and recovered

Other

• At least 4 weeks since prior myelosuppressive therapy
• More than 28 days since prior investigational drugs
• No other concurrent investigational drugs
• No other concurrent anticancer cytotoxic therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Cheverton, MD, ChB, MMED, RadT

Role: STUDY_CHAIR

Daiichi Pharmaceuticals

Locations

Medical Oncology and Hematology, P.C.

Waterbury, Connecticut, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

DAIICHI-1027A-PRT005

Identifier Type: -

Identifier Source: secondary_id

MSKCC-03016

Identifier Type: -

Identifier Source: secondary_id

CDR0000301749

Identifier Type: -

Identifier Source: org_study_id