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Sponsored by: |
Gemin X |
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Information provided by: | Gemin X |
ClinicalTrials.gov Identifier: | NCT00682981 |
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.
Condition | Intervention | Phase |
---|---|---|
Extensive-Stage Small Cell Lung Cancer |
Drug: Obatoclax Drug: Carboplatin and etoposide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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) |
Estimated Enrollment: | 188 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Phase I A: Experimental
Obatoclax for 3 hours for 3 days with carboplatin and etoposide.
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Drug: Obatoclax
A 3-hour IV infusion for 3 consecutive days of Obatoclax with carboplatin and etoposide.
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Phase I B: Experimental
Obatoclax for 24 hours for 3 days with carboplatin and etoposide.
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Drug: Obatoclax
A 24-hour IV infusion for 3 consecutive days of Obatoclax with carboplatin and etoposide.
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Phase II A: Experimental
Obatoclax for 3 hours for 3 days with carboplatin and etoposide.
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Drug: Obatoclax
A 3-hour IV infusion for 3 consecutive days of Obatoclax with carboplatin and etoposide.
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Phase II B: Experimental
Carboplatin and etoposide.
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Drug: Carboplatin and etoposide
Carboplatin and etoposide with NO Obatoclax.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Phase I:
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])
Phase II:
Measurable disease using RECIST criteria with at least one lesion
Exclusion Criteria:
Phase I and II:
Contact: Judy Schnyder | 610-640-5735 ext 448 | jschnyder@geminx.com |
Contact: Danielle Gallagher | 610-640-5735 ext 449 | dgallagher@geminx.com |
Study Director: | Jean Viallet, MD | Gemin X Pharmaceuticals |
Responsible Party: | Gemin X Pharmaceuticals ( Jean Viallet, MD ) |
Study ID Numbers: | GEM017 |
Study First Received: | May 20, 2008 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00682981 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
ES-SCLC Obatoclax |
Thoracic Neoplasms Carcinoma, Neuroendocrine Carboplatin Etoposide phosphate Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Antineoplastic Agents, Phytogenic Etoposide Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Carboplatin Etoposide phosphate Pharmacologic Actions Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Neoplasms, Germ Cell and Embryonal Adenocarcinoma Antineoplastic Agents, Phytogenic Etoposide Neoplasms, Glandular and Epithelial |