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

NCT00487669 | Completed Phase 2 Results DMC

• 1 other identifier: D-0433
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Non-small Cell Lung Cancer

Keywords

paclitaxel poliglumex; xyotax; alimta; advanced non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  CT or MRI scans of the chest will be obtained after every 2 cycles (6-week intervals +/- 7 days)

Secondary Outcomes (2)

• Time to Progression

  time from study entry until the first documented sign of progression

• Overall Survival

  time from study entry until death

Study Arms (1)

Paclitaxel Poliglumex with Pemetrexed

EXPERIMENTAL

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.

Drug: paclitaxel poliglumex, pemetrexed

Interventions

paclitaxel poliglumex, pemetrexed DRUG

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

Also known as: Xyotax, Alimta

Paclitaxel Poliglumex with Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• CTI BioPharma: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

paclitaxel poliglumex; Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: James Rigas, MD
• Organization: Dartmouth-Hitchcock Medical Center

james.r.rigas@hitchcock.org

603-650-6344

Study Officials

• James R Rigas, MD

  Norriss Cotten Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2007
• First Posted: June 18, 2007
• Study Start: October 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 9, 2014
• Results First Posted: January 9, 2014

Record last verified: 2013-11

Locations

US (1)