A Clinical Trial to Compare the Effectiveness of TLK286 (Telcyta?) and Gefitinib (Iressa®) in Non-Small Cell Lung Cancer
- Conditions
- on-small cell lung cancer, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma) or large cell carcinoma, recurrent or resistant following two prior chemotherapy regimens which must have included a platinum agent (carboplatin or cisplatin).MedDRA version: 14.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2004-000330-36-ES
- Lead Sponsor
- Telik, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 530
1. Histologically confirmed non-small cell lung cancer, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma) or large cell carcinoma. Patients with mixed tumors containing small cell lung carcinoma elements, bronchoalveolar elements or pure bronchoalveolar subtype of adenocarcinoma are not eligible.
2. Stage III or IV disease not curable with surgery, radiation or combined modality therapy at study entry
3. Recurrent or resistant disease following two prior chemotherapy regimens which must have included a platinum agent (carboplatin or cisplatin), [e.g. Patients must have received treatment with a platinum agent (carboplatin or cisplatin) as neoadjuvant or adjuvant therapy in combination with surgery; as treatment for metastatic disease; or in combined modality chemoradiation for stage III disease.]
4. Measurable disease according to RECIST criteria, with documented tumor progression. Pleural effusions, ascites, osseous metastases, and lesions located in previously irradiated areas are not considered measurable.
5. Eastern Co-Operative Group (ECOG) performance status of 0?2
6. ? 18 years of age
7. Adequate liver and renal function as evidenced by the following:
? Creatinine ? 2.0 mg/dL or calculated creatinine clearance of at least 60 mL/min by Cockcroft-Gault Equation
? Total bilirubin ? 2.0 mg/dL (except when Gilbert syndrome is clearly documented and other LFTs are normal)
? ALT ? 3 x the upper limit of normal (ULN). If the patient has hepatic metastases, then ALT ? 5 x the ULN
? Alkaline phosphatase ? 5 x the ULN (except when bone metastases are present in the absence of any liver disorders)
? Albumin ? 3.0 g/dL
8. Adequate bone marrow reserve as indicated by:
? ANC ? 1,500 cells/mm3
? Platelet count ? 100,000 cells/mm3
? Hemoglobin ? 9.0 g/dL
9. Willing and able to comply with the protocol for the duration of the study
10. Written informed consent given prior to any study-specific screening procedures
11. Women and men of child-bearing potential enrolled in the study must agree to practice an effective method of birth control during the study and for at least six months after receiving their last study treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 335
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 195
1. Treatment with more than two prior chemotherapy regimens
2. Histologically confirmed mixed tumors containing small cell lung carcinoma elements, bronchoalveolar elements, or pure bronchoalveolar subtype of adenocarcinoma
3. Treatment with chemotherapy or radiotherapy (except limited in nature) within three weeks of study entry or failure to recover from the toxic effects of any of these therapies within six weeks prior to study entry
4. History of bone marrow transplantation or stem cell support
5. Leptomeningeal metastases or carcinomatous meningitis
6. Known history of CNS metastasis are ineligible unless the patient has had treatment with surgery or radiation therapy, is neurologically stable, does not require oral or intravenous steroids or anticonvulsants
7. A history of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, incidental endometrial cancer Stage I, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease-free for at least three years (e.g., bladder cancer, head and neck cancer). Patients with elevated PSA in the absence of known metastatic prostate cancer (even if there is previously treated prostate cancer) are eligible. These patients should be discussed with the medical monitor prior to study entry
8. Routine prophylactic use of G-CSF or GM-CSF within two weeks prior to study entry
9. Evidence of gross hematuria at the time of study entry
10. Uncontrolled hypercalcemia (serum calcium ? 11.0 mg/dL). Calcium should be corrected for serum albumin
11. Serious uncontrolled intercurrent infections (bacterial or viral) or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for study entry
12. History of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the Investigator to be clinically significant, precluding informed consent or adversely affecting ability to comply with study procedures
13. Pregnant or lactating women and women of child-bearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-child-bearing potential.
14. Failure to recover from any prior surgery, or major surgery within three weeks of study entry (other than a minor biopsy or placement of a venous access device)
15. Grade 3 or 4 peripheral neuropathy
16. Known history of HIV positivity (regardless of immune status)
17. Weight loss ? 10% within six weeks prior to study entry
18. Uncontrolled pleural effusion (defined as requiring two or more thoracenteses within four weeks prior to study entry)
19. Known history of prior TLK286 therapy
20. Known history of prior gefitinib therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method