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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cell Therapeutics
ClinicalTrials.gov Identifier:
NCT00576225
First received: December 17, 2007
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Cell Therapeutics:

Primary Outcome Measures:
  • Survival [ Time Frame: up to 3 years post treatment ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576225

  Show 44 Study Locations
Sponsors and Collaborators
Cell Therapeutics
Investigators
Study Director: Jack W. Singer, M.D. Cell Therapeutics
  More Information

No publications provided

Responsible Party: Cell Therapeutics
ClinicalTrials.gov Identifier: NCT00576225     History of Changes
Other Study ID Numbers: PGT307
Study First Received: December 17, 2007
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Therapeutics:
NSCLC
women
CT-2103
paclitaxel
carboplatin

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Estradiol
Carboplatin
Paclitaxel
 Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013