Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase II Study of Combination of Paclitaxel Poliglumex and Alimta for Advanced Non-small Cell Lung Cancer (NSCLC)

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.
 
ClinicalTrials.gov Identifier: NCT00487669
Recruitment Status : Completed
First Posted : June 18, 2007
Results First Posted : January 9, 2014
Last Update Posted : January 9, 2014
Sponsor:
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE June 14, 2007
First Posted Date  ICMJE June 18, 2007
Results First Submitted Date  ICMJE November 21, 2013
Results First Posted Date  ICMJE January 9, 2014
Last Update Posted Date January 9, 2014
Study Start Date  ICMJE October 2006
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2008)
To Evaluate the Overall Response Rate (Complete Plus Partial Responses by RECIST Criteria) to the Combination of Paclitaxel Poliglumex and Pemetrexed as Therapy in Patients With Advanced NSCLC. [ Time Frame: CT or MRI scans of the chest will be obtained after every 2 cycles (6-week intervals +/- 7 days) ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2007)
To Evaluate the Overall Response Rate (Complete Plus Partial Responses by RECIST Criteria) to the Combination of Paclitaxel Poliglumex and Pemetrexed as Therapy in Patients With Advanced NSCLC.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
  • Time to Progression [ Time Frame: time from study entry until the first documented sign of progression ]
  • Overall Survival [ Time Frame: time from study entry until death ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2007)
To evaluate the safety and adverse event profile of the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of Combination of Paclitaxel Poliglumex and Alimta for Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title  ICMJE Phase II Study of the Combination of Paclitaxel Poliglumex (CT-2103, Xyotax) and Pemetrexed (Alimta) for the Treatment of Patients With Advanced Non-small Cell Lung Cancer.
Brief Summary This is a non-randomized, single-arm, single-institution, open label, two-stage phase II and dose-ranging study designed to evaluate the efficacy and safety of paclitaxel poliglumex in combination with pemetrexed in patients with advanced stage IIIB or stage IV NSCLC.
Detailed Description

Primary objective

To evaluate the overall response rate (complete plus partial responses by RECIST criteria) to the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.

Secondary Objectives

To evaluate the safety and adverse event profile of the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.

To evaluate the duration of response, time to progression, and overall survival of advanced NSCLC treated with the combination of paclitaxel poliglumex and pemetrexed.

To compare the overall response rate using three-dimensional reconstruction of target lesions by Medical Metrx Solutions (MMS) and RECIST criteria.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Non-small Cell Lung Cancer
Intervention  ICMJE Drug: paclitaxel poliglumex, pemetrexed
The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued
Other Names:
  • Xyotax
  • Alimta
Study Arms  ICMJE Experimental: Paclitaxel Poliglumex with Pemetrexed
The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
Intervention: Drug: paclitaxel poliglumex, pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2012)
14
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2007)
45
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of locally advanced and/or metastatic NSCLC (Stage IIIB or IV).
  • Bidimensionally measurable lesions or unidimensionally evaluable lesions.
  • Age ≥ 18 years.
  • At least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST), which has not been previously treated with local therapy (e.g. radiation therapy, chemoembolization, surgery, etc.).
  • May have received prior chemotherapy (including taxanes) for advanced NSCLC.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Life expectancy > 12 weeks.
  • No active infections.
  • Adequate liver and bone marrow function.
  • AST<2.5 x ULN, bilirubin <1.5x ULN, alkaline phosphatase<2.5 x ULN (unless bone origin and no liver metastases are documented).
  • ANC ≥ 1,500/uL, platelet count ≥ 100,000/uL.
  • Normal PT and PTT.
  • Bisphosphates initiated prior to study entry will be permitted. However, initiation of bisphosphonates following study entry is not permitted.
  • Patients with treated brain metastases must be neurologically stable.
  • At least 3 weeks since last chemotherapy and recovered from treatment-related adverse events ≤ grade 1.
  • At least 3 weeks since prior radiation and recovered from treatment-related adverse events ≤ grade 1.
  • Women of childbearing potential are eligible for the study, provided they have a negative serum or urine pregnancy test within three days of study entry, and an adequate method of contraception is used. Acceptable methods of birth control include barrier methods (condoms, diaphragms with spermicide) or intrauterine devices (IUD). Women whose sole sexual partner is infertile, or who are not sexually active, are also eligible.
  • Able to provide written informed consent.

Exclusion Criteria:

  • Grade 2 or greater peripheral neuropathy, according to the National Cancer Institute-Common Toxicity Criteria.
  • Clinically significant pleural, pericardial or abdominal effusions.
  • Untreated brain metastases.
  • Patients with previously diagnosed brain metastases will be eligible if they are neurologically stable and have recovered from the effects of radiotherapy or surgery (≤ grade 2).
  • Patients with brain metastases must have at least one other site of measurable disease.
  • Concurrent radiotherapy.
  • Other concurrent cancer treatment-related investigational agent. Investigational supportive care medications are permitted.
  • Concurrent treatment with unfractionated heparin or warfarin.
  • History of radiotherapy encompassing greater than 50% of the marrow-bearing skeleton.
  • Prior bone marrow or stem cell transplant.
  • History of other active malignancy within the last year requiring chemotherapy, not including curatively-treated carcinoma in situ of the cervix, or non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma).
  • Uncontrolled infection.
  • Active bleeding, or history of bleeding requiring transfusion within 2 weeks of study entry.
  • Active cardiac disease, as defined as:
  • Current history of uncontrolled or symptomatic angina.
  • History of arrhythmias requiring medications or clinically significant arrhythmias, with the exception of uncomplicated atrial fibrillation.
  • Myocardial infarction < 6 months from study entry.
  • Any other cardiac conditions, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00487669
Other Study ID Numbers  ICMJE D-0433
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE CTI BioPharma
Investigators  ICMJE
Principal Investigator: James R Rigas, MD Norriss Cotten Cancer Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP