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A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide With or Without Obatoclax Administered Every 3 Weeks to Patients With Extensive- Stage Small Cell Lung Cancer (ES-SCLC)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Extensive-stage Small Cell Lung Cancer

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Trial Information

A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide With or Without Obatoclax Administered Every 3 Weeks to Patients With Extensive- Stage Small Cell Lung Cancer (ES-SCLC)


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 obatoclax with or without carboplatin and etoposide every three weeks will
be evaluated for response rates.


Inclusion Criteria:



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

Exclusion Criteria:

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the recommended Phase II dose of obatoclax administered as a 3-hour or 24-hour infusion for 3 consecutive days in Phase I, and response rate in Phase II.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Jean Viallet, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gemin X Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

GEM017

NCT ID:

NCT00682981

Start Date:

May 2008

Completion Date:

November 2011

Related Keywords:

  • Extensive-Stage Small Cell Lung Cancer
  • ES-SCLC
  • Obatoclax
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Virginia Oncology AssociatesNewport News, Virginia  23606
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Arizona Clinical Research CenterTucson, Arizona  85712
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Tyler Cancer CenterTyler, Texas  75702
H. Lee Moffitt Cancer CenterTampa, Florida  33612
University of ChicagoChicago, Illinois  60637
Florida Cancer InstituteNew Port Richey, Florida  34652
The West ClinicMemphis, Tennessee  38120
Peninsula Cancer InstituteNewport News, Virginia  23601
Mid Ohio Oncology/Hematology, Inc.Columbus, Ohio  43213
University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania  19104
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Clearview Cancer InstituteHuntsville, Alabama  35805
Northwest Georgia Oncology CentersMarietta, Georgia  30060
Wheeling HospitalWheeling, West Virginia  26003
Cancer Center of KansasWichita, Kansas  67214
Kalamazoo Hematology and OncologyKalamazoo, Michigan  49048
McLeod Cancer & Blood CenterJohnson City, Tennessee  37604
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
UT Southwestern Medical Center at DallasDallas, Texas  75390
Mayo Clinic-ArizonaScottsdale, Arizona  85259
City of Hope and Beckman Research InstituteDuarte, California  91010
University of California-San Diego Moores Cancer CenterLaJolla, California  92093-0987
Georgetown University Hospital-Lombardi Comprehensive Cancer CenterWashington, District of Columbia  20007
University of Miami-Sylvester Cancer CenterMiami, Florida  33136
Iowa Blood and Cancer Center, PLCCedar Rapids, Iowa  52402
James Brown Cancer CenterLouisville, Kentucky  40202
Cancer Care Associates-Oklahoma CityOklahoma City, Oklahoma  73112
Cancer Care Associates-TulsaTulsa, Oklahoma  74136
Greater Philadelphia Cancer and Hematology SpecialistsPhiladelphia, Pennsylvania  19114
BaylorDallas, Texas  75246