Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00061854
First received: June 5, 2003
Last updated: May 15, 2012
Last verified: May 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: soblidotin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
| Study Start Date: | April 2003 |
| Study Completion Date: | May 2005 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061854
Locations
| United States, Connecticut | |
| Medical Oncology and Hematology, P.C. | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
| Study Chair: | Peter Cheverton, MD, ChB, MMED, RadT | Daiichi Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00061854 History of Changes |
| Other Study ID Numbers: | CDR0000301749, DAIICHI-1027A-PRT005, MSKCC-03016 |
| Study First Received: | June 5, 2003 |
| Last Updated: | May 15, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Daiichi Sankyo Inc.:
|
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 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Soblidotin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013