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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Peter Cheverton, MD, ChB, MMED, RadT

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000301749

NCT ID:

NCT00061854

Start Date:

April 2003

Completion Date:

May 2005

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Medical Oncology and Hematology, P.C.Hamden, Connecticut  06518