A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Completed · Phase 1/Phase 2

Conditions studied: Extensive-stage Small Cell Lung Cancer

In brief

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 II portion will evaluate the response rate to this regimen.

Key facts

Study ID: NCT00682981
Run by: Gemin X
People needed: 218
Starts: 2008-05-01
Expected to finish: 2011-11-01
Last updated by the study team: 2016-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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])
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
Phase II:
Pathological or cytological confirmation of SCLC
ES-SCLC
Measurable disease using RECIST criteria with at least one lesion
2.0 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

You may not qualify if…

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

Where it is running

Northwest Alabama Cancer Center — Muscle Shoals, Alabama, United States
Mayo Clinic-Arizona — Scottsdale, Arizona, United States
Arizona Clinical Research Center — Tucson, Arizona, United States
City of Hope and Beckman Research Institute — Duarte, California, United States
University of California-San Diego Moores Cancer Center — La Jolla, California, United States
Georgetown University Hospital-Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
Integrated Community Oncology Network — Jacksonville, Florida, United States
University of Miami-Sylvester Cancer Center — Miami, Florida, United States
Florida Cancer Institute — New Port Richey, Florida, United States
H. Lee Moffitt Cancer Center — Tampa, Florida, United States
Northwest Georgia Oncology Centers — Marietta, Georgia, United States
University of Chicago — Chicago, Illinois, United States
Iowa Blood and Cancer Center, PLC — Cedar Rapids, Iowa, United States
Cancer Center of Kansas — Wichita, Kansas, United States
James Brown Cancer Center — Louisville, Kentucky, United States
Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
Kalamazoo Hematology and Oncology — Kalamazoo, Michigan, United States
Mid Ohio Oncology/Hematology, Inc. — Columbus, Ohio, United States
Cancer Care Associates-Oklahoma City — Oklahoma City, Oklahoma, United States
Cancer Care Associates-Tulsa — Tulsa, Oklahoma, United States
University of Pennsylvania Abramson Cancer Center — Philadelphia, Pennsylvania, United States
Greater Philadelphia Cancer and Hematology Specialists — Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas — Greenville, South Carolina, United States
McLeod Cancer & Blood Center — Johnson City, Tennessee, United States
Clearview Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.