Status:
COMPLETED
A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Lead Sponsor:
Gemin X
Collaborating Sponsors:
Cephalon
Conditions:
Extensive-stage Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The Phase I portion of this protocol will determine the best phase II dose and schedule of obatoclax with carboplatin and etoposide in patients with extensive-stage small cell lung cancer. The Phase I...
Detailed Description
In the Phase I portion, both 3 hour and 24 hour infusions of obatoclax with carboplatin and etoposide every 3 weeks will be evaluated at different doses. In the Phase II portion, 3 hour infusions of o...
Eligibility Criteria
Inclusion
- Phase I:
- Pathological or cytological confirmation of SCLC
- ES-SCLC
- Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) with at least one lesion ≥2.0 cm using conventional technique or ≥1.0 cm with spiral computed tomography (CT) scan in a single dimension
- No previous chemotherapy
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
- Normal organ function defined as: absolute neutrophil count (ANC)
- 1500/mm3, platelets ≥100,000/mm3, total bilirubin ≤ upper limit of normal (ULN) or total bilirubin ≤ 3.0 if liver metastases are present, alanine aminotransferase (serum glutamic pyruvic transaminase) (ALT \[SGPT\])
- 5 ´ ULN or ALT/SGPT ≤ 5 ´ ULN if liver metastases are present, and creatinine within normal institutional limits or calculated creatinine clearance ≥50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Negative serum or urine pregnancy test result prior to study entry. In addition, women of child-bearing potential and men with partners of child-bearing potential must agree to use acceptable forms of birth control (those that result in less than 1% pregnancy/year when used correctly: implants, injectables, combined oral contraceptives, some IUDs, vasectomy of a male partner, sexual abstinence)
- Ability to understand and willingness to sign a written informed consent form
- Phase II:
- Pathological or cytological confirmation of SCLC
- ES-SCLC
- Measurable disease using RECIST criteria with at least one lesion
- 0 cm using conventional technique or ≥1.0 cm with spiral CT scan in a single dimension
- No previous chemotherapy
- Age ≥18 years
- ECOG Performance Status ≤2;
- Normal organ function defined as: ANC ≥1500/mm3, platelets ≥100,000/mm3, total bilirubin ≤ULN or total bilirubin ≤ 3.0 if liver metastases are present, ALT (SGPT) ≤2.5 ´ ULN or ALT/SGPT ≤ 5 ´ ULN if liver metastases are present, and creatinine within normal institutional limits or calculated creatinine clearance ≥50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Negative serum or urine pregnancy test result prior to study entry. In addition, women of child-bearing potential and men with partners of child-bearing potential must agree to use acceptable forms of birth control (those that result in less than 1% pregnancy/year when used correctly: implants, injectables, combined oral contraceptives, some IUDs, vasectomy of a male partner, sexual abstinence)
- Ability to understand and willingness to sign a written informed consent form
Exclusion
- Phase I and II:
- Other investigational or commercial agents or therapies administered with the intent to treat the patient's malignancy
- History of allergic reactions attributed to components of the obatoclax formulation (Polysorbate 20 and PEG 300)
- History of seizure disorders unrelated to SCLC brain metastases, or presence of symptomatic brain metastases
- Uncontrolled,intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled systemic infection considered opportunistic, lifethreatening,or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; clinically significant cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women and women who are breast feeding;
- human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00682981
Start Date
May 1 2008
End Date
November 1 2011
Last Update
July 21 2016
Active Locations (75)
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1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
2
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
3
Mayo Clinic-Arizona
Scottsdale, Arizona, United States, 85259
4
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715