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A Phase II, Open Label Study Of T138067-Sodium In A Second-Line Setting In Non-Small-Cell Lung Cancer Patients With Locally Advanced Or Metastatic Disease Who Have Failed First-Line Therapy With a Taxane


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Phase II, Open Label Study Of T138067-Sodium In A Second-Line Setting In Non-Small-Cell Lung Cancer Patients With Locally Advanced Or Metastatic Disease Who Have Failed First-Line Therapy With a Taxane


OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced
or metastatic non-small cell lung cancer who have failed first-line therapy with a taxane
when treated with T138067 sodium. II. Determine the qualitative and quantitative toxic
effects of this drug in these patients. III. Determine the number of patients who progress
when treated with this drug. IV. Determine the duration of response, time to disease
progression, and median survival of patients treated with this drug. V. Correlate the toxic
effects of this drug with peak plasma levels in this patient population.

OUTLINE: This is a multicenter study. Patients receive T138067 sodium IV over 3 hours on
days 1, 8, and 15. Treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity. Patients are followed every 3 months after study completion.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 9 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC)
Locally advanced or metastatic disease Received a prior first-line taxane (as a single
agent or component of a combination regimen) as the only chemotherapy for locally advanced
or metastatic disease Any amount of prior adjuvant chemotherapy allowed Bidimensionally
measurable disease outside the field of prior radiotherapy Amenable to radiologic imaging
techniques No clinically apparent CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper
limit of normal (ULN) AST and ALT no greater than 3 times ULN Albumin greater than 2.5
g/dL No history of Gilbert's syndrome Renal: Creatinine no greater than 1.5 times ULN
Other: No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix No other severe disease,
infection, or comorbidity that would preclude study participation No known defect of
glutathione metabolism Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy or therapeutic
biologic response modifiers No concurrent routine or prophylactic filgrastim (G-CSF) or
sargramostim No concurrent epoetin alfa Chemotherapy: See Disease Characteristics At least
4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No
other concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent hormonal therapy
for NSCLC Radiotherapy: See Disease Characteristics At least 2 weeks since prior
limited-field radiotherapy not involving the hematopoietic bone marrow and recovered At
least 4 weeks since prior radiotherapy to no more than 25% of the hematopoietic bone
marrow and recovered No prior wide-field radiotherapy to the pelvis No concurrent
radiotherapy (including palliative radiotherapy) Surgery: At least 4 weeks since prior
major surgery Other: At least 4 weeks since prior investigational agents No concurrent
anticonvulsants unless required for study drug-related toxicity No concurrent high-dose
acetaminophen (i.e., at least 4 g/day) No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sean McCarthy

Investigator Role:

Study Chair

Investigator Affiliation:

Tularik

Authority:

United States: Federal Government

Study ID:

CDR0000068798

NCT ID:

NCT00022243

Start Date:

October 2000

Completion Date:

Related Keywords:

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

Name

Location

UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838