Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer

NCT00005093

Last updated date
Study Location
Cedars-Sinai Comprehensive Cancer Center
Los Angeles, California, 90048, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Lung CancerSunitinib as a Second-line Treatment for Patients With Recurrent Small Cell Lung Cancer
NCT00620347
  1. Goyang-si, Gyeonggi-do
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Lung CancerIrinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer
NCT00387660
  1. Sacramento, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Lung CancerPF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer
NCT01000025
  1. Arcadia, California
  2. Skokie, Illinois
  3. Buenos Aires, B1878dvb Bs. As.
  4. Berazategui, Provincia De Buenos Aires
  5. Cordoba,
  6. San Miguel de Tucuman,
  7. Camperdown, New South Wales
  8. Concord, New South Wales
  9. Kogarah, New South Wales
  10. Randwick, New South Wales
  11. St. Leonards, New South Wales
  12. Waratah, New South Wales
  13. Westmead, New South Wales
  14. Chermside, Queensland
  15. Nambour, Queensland
  16. Adelaide, South Australia
  17. Clayton, Victoria
  18. Footscray, Victoria
  19. Frankston, Victoria
  20. Geelong, Victoria
  21. Heidelberg, Victoria
  22. Perth, Western Australia
  23. Porto Alegre, Rio Grande Do Sul
  24. Brasilia, Sao Paulo
  25. Barretos, SP
  26. Porto Alegre, SP
  27. Belo Horizonte,
  28. Centro,
  29. Salvador,
  30. Sao Paulo,
  31. Edmonton, Alberta
  32. Abbotsford, British Columbia
  33. Surrey, British Columbia
  34. Vancouver, British Columbia
  35. Saint John, New Brunswick
  36. St. John's, Newfoundland and Labrador
  37. Halifax, Nova Scotia
  38. Hamilton, Ontario
  39. Kingston, Ontario
  40. London, Ontario
  41. Oshawa, Ontario
  42. Ottawa, Ontario
  43. Sault Ste. Marie, Ontario
  44. St. Catharines, Ontario
  45. Sudbury, Ontario
  46. Toronto, Ontario
  47. Windsor, Ontario
  48. Montreal, Quebec
  49. Montreal, Quebec
  50. Regina, Saskatchewan
  51. Saskatoon, Saskatchewan
  52. Aviano, PN
  53. Saronno, VA
  54. Benevento,
  55. Fano,
  56. Genova,
  57. Meldola,
  58. Messina,
  59. Messina,
  60. Milan,
  61. Mirano,
  62. Napoli,
  63. Napoli,
  64. Padova,
  65. Palermo,
  66. Piacenza,
  67. Rome,
  68. Rome,
  69. San Giovanni Rotondo,
  70. Sondalo,
  71. GyeongGi-Do,
  72. Jeongnam,
  73. Seoul,
  74. Seoul,
  75. Seoul,
  76. Auckland,
  77. Lima,
  78. Lima,
  79. Lima,
  80. Cebu City,
  81. Makati City,
  82. Manila,
  83. Taichung,
  84. Tainan,
  85. Taipei,
  86. Bangkok,
  87. Bangkok,
  88. Bangkok,
  89. Chiangmai,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer
Official Title  ICMJE A Randomized Double-Blind, Placebo-Controlled, Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion as Second-Line Treatment of Patients With Advanced Nonsmall Cell Lung Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine plus CI-994 is more effective than gemcitabine alone for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced non-small cell lung cancer.

Detailed Description

OBJECTIVES: I. Determine the efficacy and safety of gemcitabine with or without CI-994 in patients with advanced non-small cell lung cancer.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to performance status and are randomized to one of two treatment arms. Arm I: Patients receive CI-994 orally on days 1-21 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Arm II: Patients receive placebo capsules orally on days 1-21 and gemcitabine as in arm I. Treatment repeats every 28 days as long as medically appropriate (absence of disease progression or unacceptable toxicity).

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: gemcitabine hydrochloride
  • Drug: tacedinaline
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2001
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent, locally advanced, or metastatic, unresectable non-small cell lung cancer Failed or relapsed after one prior platinum containing regimen (cisplatin or carboplatin) as first line therapy Prior brain metastases allowed if resection and/or radiotherapy completed, no worsening of CNS symptoms, and at least 1 month since prior corticosteroids

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (no greater than 5 times ULN in patients with liver metastases) Renal: Creatinine clearance at least 50 mL/min Other: Able to swallow intact study capsules No active infection No life threatening illness (other than tumor) No prior malignancy within the past 5 years except well controlled nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No more than one prior regimen of chemotherapy No prior gemcitabine No prior CI-994 At least 4 weeks since prior maintenance or consolidation therapy (e.g., matrix metalloprotein inhibitors) Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy to primary site Surgery: Not specified

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00005093
Other Study ID Numbers  ICMJE PD-994-013
CDR0000067735
ILEX-994-013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair:Kathryn Kimmel, PhDPfizer Incorporated - Ann Arbor
PRS Account Pfizer
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP