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A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.

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. Identifier: NCT00269828
Recruitment Status : Terminated
First Posted : December 26, 2005
Last Update Posted : February 14, 2007
Information provided by:
CTI BioPharma

Brief Summary:
This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2. Study drug will be administered on day 1 of each 21 day cycle

Condition or disease Intervention/treatment Phase
NSCLC Drug: paclitaxel Drug: paclitaxel poliglumex Phase 3

Detailed Description:
See Summary

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paclitaxel Poliglumex (CT-2103) vs. Paclitaxel for the Treatment of Women With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) Who Are Performance Status 2.
Study Start Date : December 2005
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Primary Outcome Measures :
  1. The primary objective of this study is to compare the overall survival of female patients randomized to CT-2103 to that of female patients randomized to paclitaxel.

Secondary Outcome Measures :
  1. Secondary objectives are to compare the progression-free survival, response rate, disease control, clinical benefit, quality of life, and the safety and tolerability of the treatment arms.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Female.
  2. Histologically- or cytologically-confirmed diagnosis of NSCLC.
  3. ECOG performance score of 2.
  4. Patients who meet one of the following criteria:

    • Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or
    • Stage IV.
  5. Age greater than or equal to 18 years.
  6. Adequate bone marrow function
  7. Adequate renal function
  8. Adequate hepatic function
  9. Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site’s institutional standards.
  10. Patients who have had major surgery must be fully recovered from the surgery.
  11. Ability to comply with the visit schedule and assessments required by the protocol.
  12. For patients of reproductive potential, commitment to use adequate contraception.
  13. Signed approved informed consent, with understanding of study procedures.
  14. Agreement to begin study therapy within 8 calendar days after randomization.

Exclusion Criteria:

  1. Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103).
  2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
  3. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
  4. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
  5. Grade 2 or greater neuropathy.
  6. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. (If unstable neurologic symptoms resulted from brain metastases, patient must meet inclusion criteria number 9).
  7. Clinically significant active infection for which active therapy is underway.
  8. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent.
  9. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable.
  10. Pregnant women or nursing mothers.
  11. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

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 identifier (NCT number): NCT00269828

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Sponsors and Collaborators
CTI BioPharma

Layout table for additonal information Identifier: NCT00269828    
Obsolete Identifiers: NCT00317824
Other Study ID Numbers: PGT305
First Posted: December 26, 2005    Key Record Dates
Last Update Posted: February 14, 2007
Last Verified: February 2007
Keywords provided by CTI BioPharma:
Non-small cell lung cancer
PS 2
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Albumin-Bound Paclitaxel
Paclitaxel poliglumex
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action