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

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00061854

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: soblidotin	Phase 2

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study Of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, To Patients With Progressive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) Following Treatment With Platinum-Based Chemotherapy

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Oncology and Hematology, P.C.	Waterbury	Connecticut	United States	06708
2	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
3	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021