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CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by CTI BioPharma.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: December 19, 2007
Last Update Posted: May 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CTI BioPharma
This study is designed to test whether CT-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml.

Condition Intervention Phase
NSCLC Drug: CT-2103/carboplatin Drug: paclitaxel/carboplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol > 25 pg/mL

Resource links provided by NLM:

Further study details as provided by CTI BioPharma:

Primary Outcome Measures:
  • Survival [ Time Frame: up to 3 years post treatment ]

Secondary Outcome Measures:
  • progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety [ Time Frame: up to 3 years post treatment ]

Estimated Enrollment: 450
Study Start Date: September 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug: CT-2103/carboplatin
CT-2103 (175 mg/m2 10 min IV infusion) and carboplatin (AUC 6, 30 min IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
Active Comparator: Control Drug: paclitaxel/carboplatin
Paclitaxel (175 mg/m2, 3 hr IV infusion) and carboplatin (AUC 6) (30 minute IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Women with baseline estradiol >25 pg/mL
  2. Histologically- or cytologically-confirmed diagnosis of NSCLC.
  3. ECOG performance score (PS) of 0, 1, or 2.
  4. Patients must meet one of the following criteria have either (1) Recurrent disease following completion of radiation or surgery, (2) Stage IIIB disease and not be a candidate for combined modality therapy (primary radiation therapy or surgery), or (3) Stage IV disease.
  5. At least 18 years of age.
  6. Adequate bone marrow function
  7. Adequate renal function
  8. Adequate hepatic function
  9. Life expectancy ≥12 weeks

Exclusion Criteria:

  1. Known hypersensitivity to the excipients or the study drug (either CT-2103, paclitaxel, or carboplatin that the patient will receive.
  2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
  3. Weight loss >10% in previous 6 months
  4. LDH > 2.5X IULN
  5. Both LDH > 1.5X IULN and ≥ 5% weight loss in previous 6 months
  6. BMI >35
  7. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
  8. Local palliative radiotherapy < 7 days before randomization.
  9. Radiation with curative intent < 30 days before randomization.
  10. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
  11. Grade 2 or greater neuropathy.
  12. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization.
  13. Clinically significant active infection for which active therapy is underway.
  14. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent.
  15. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization.
  16. Pregnant women or nursing mothers.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576225

  Show 44 Study Locations
Sponsors and Collaborators
CTI BioPharma
Study Director: Jack W. Singer, M.D. CTI BioPharma
  More Information

Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT00576225     History of Changes
Other Study ID Numbers: PGT307
First Submitted: December 17, 2007
First Posted: December 19, 2007
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by CTI BioPharma:

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs