Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	Pharmaceutical / Industry	DAIICHI-1027A-PRT005 MSKCC-03016, NCT00061854

Objectives

1. 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.
2. Determine the time to tumor progression in patients treated with this drug.
3. Determine the median survival time and 12-month survival rate of patients treated with this drug.
4. Determine the quantitative and qualitative toxic effects of this drug in these patients.
5. Determine the pharmacokinetics of this drug in these patients.

Entry 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

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

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/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Daiichi Sankyo, Incorporated

Peter Cheverton, MD, ChB, MMED, RadT, Protocol chair		Ph: 44-171-936-2850

Registry Information
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
Trial Start Date		2003-04-02
Registered in ClinicalTrials.gov		NCT00061854
Date Submitted to PDQ		2003-04-02
Information Last Verified		2005-05-04

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