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Home > "S" Clinical Trials Conditions > Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer  Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 3A non-small cell lung cancer
Status: Recruiting
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: 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 progressivelocally advanced or metastaticnon-small cell lung cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MilaynaSubar, Study Chair, Daiichi Pharmaceuticals
Medical Oncology Associates of Wyoming Valley, P.C. *Recruiting*
Kingston, Pennsylvania, 18704-5527
United States
Recruiting Bruce Saidman 570-288-7231
Medical Oncology and Hematology, P.C. *Recruiting*
Waterbury, Connecticut, 06708
United States
Recruiting Kert Sabbath 203-755-6311
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Naiyer Rizvi 212-639-3204
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Shirish Gadgeel 313-745-8389
South Shore Hematology Oncology Associates, P.C. *Recruiting*
Rockville Centre, New York, 11570
United States
Recruiting Ivan Rothman 516-536-1455
Additional Information:
Study ID Numbers: CDR0000301749; MSKCC-03016,DAIICHI-1027A-PRT005
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061854
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
2. Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
3. Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
4. Gefitinib and Celecoxib in Treating Patients With Refractory Non-Small Cell Lung Cancer
5. Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
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Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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