Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054210
First received: February 5, 2003
Last updated: July 23, 2008
Last verified: July 2004
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating stage IIIB, stage IV, or recurrent non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel plus carboplatin to that of paclitaxel plus carboplatin in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: paclitaxel
Drug: paclitaxel poliglumex
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: CT-2103/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2003
Detailed Description:

OBJECTIVES:

  • Compare the efficacy of polyglutamate paclitaxel (CT-2103) and carboplatin vs paclitaxel and carboplatin, in terms of duration of overall survival, in patients with stage IIIB or IV or recurrent non-small cell lung cancer who have a performance status of 2.
  • Compare the disease control (percentage of patients with no disease progression for at least 12 weeks) and time to progression in patients treated with these regimens.
  • Compare the response rate in patients with measurable disease treated with these regimens.
  • Compare the improvement in lung cancer symptoms in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, disease stage (IV vs other), geographic location (US vs Western Europe and Canada vs the rest of the world), and prior brain metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive polyglutamate paclitaxel (CT-2103) IV over 10 minutes and carboplatin IV over 30 minutes on day 1.
  • Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.

Treatment repeats in both arms every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 13 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

    • Locally advanced or recurrent disease previously treated with radiotherapy and/or surgery
    • Stage IIIB and not a candidate for combined modality therapy
    • Stage IV
  • No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology
  • Cytological diagnosis must be based on the following:

    • No cellular diagnosis by sputum cytology alone
    • Cytologic specimens obtained from brushings, washings, or needle aspiration of a defined lesion or pleural effusion are acceptable
  • Measurable or nonmeasurable disease
  • Brain metastases allowed provided patient received prior standard antitumor therapy for CNS metastases (e.g., whole brain radiotherapy, stereotactic radioablation, or surgery) and the following conditions are met:

    • Neurologic function stable for at least 2 weeks before study entry
    • Off steroid therapy or on a tapering regimen
    • Recovered from prior therapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2.5 times ULN (except for laboratory documentation that demonstrates bone origin)

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • No unstable angina
  • No myocardial infarction within the past 6 months
  • Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for at least 6 months prior to study entry

Neurologic

  • See Disease Characteristics
  • No neuropathy greater than grade 1
  • No evidence of unstable neurological symptoms within the past 4 weeks (2 weeks for neurological symptoms due to brain metastases)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide)
  • No clinically significant active infection
  • No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer
  • No other unstable medical conditions
  • No circumstance that would preclude study completion or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior systemic biologic agent for lung cancer

Chemotherapy

  • See Disease Characteristics
  • No prior systemic therapy for lung cancer including radiosensitizing agents

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior major surgery

Other

  • More than 12 weeks since prior participation in any research study or treatment with investigational drugs
  • Recovered from prior investigational therapy or stable for 4 weeks before study treatment
  • No other concurrent investigational drugs
  • No other concurrent systemic antitumor therapy
  • No concurrent amifostine
  • Concurrent bisphosphonates allowed
  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: NCT00054210

  Show 35 Study Locations
Sponsors and Collaborators
CTI BioPharma
Investigators
Study Chair: Melinda Bomar PPD, Incorporated
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00054210     History of Changes
Other Study ID Numbers: CDR0000269910, CTI-PGT303
Study First Received: February 5, 2003
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

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

ClinicalTrials.gov processed this record on July 24, 2014