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

This study has been terminated.
Sponsor:
Information provided by:
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT00269828
First received: December 22, 2005
Last updated: February 13, 2007
Last verified: February 2007
  Purpose

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 Intervention Phase
NSCLC
Drug: paclitaxel
Drug: paclitaxel poliglumex
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by CTI BioPharma:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 600
Study Start Date: December 2005
Estimated Study Completion Date: December 2006
Detailed Description:

See Summary

  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269828

  Show 143 Study Locations
Sponsors and Collaborators
CTI BioPharma
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00269828     History of Changes
Obsolete Identifiers: NCT00317824
Other Study ID Numbers: PGT305, PIONEER
Study First Received: December 22, 2005
Last Updated: February 13, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by CTI BioPharma:
Non-small cell lung cancer
NSCLC
PS 2
female
chemotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 23, 2014