We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Abraxane and Alimta in Advanced Solid Tumors

This study has been terminated.
(Practice patterns with pemetrexed have evolved.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470548
First Posted: May 7, 2007
Last Update Posted: May 18, 2017
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.
Collaborators:
Celgene
Eli Lilly and Company
Information provided by (Responsible Party):
University of California, Davis
May 3, 2007
May 7, 2007
January 17, 2017
May 18, 2017
May 18, 2017
April 2007
October 2014   (Final data collection date for primary outcome measure)
  • Number of Participants With Dose Limiting Toxicities [ Time Frame: Up to21 days ]
    Dose limiting toxicity (DLT) was defined as any of the following occurring during the first cycle: Grade 4 thrombocytopenia, or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion, febrile neutropenia, neutropenia with documented infection. Non-hematologic DLT included any other ≥ grade 3 non-hematologic toxicity that was clinically significant and considered by the investigator to be related to study drug. Alopecia and grade 3 allergic reaction/hypersensitivity with infusion were not considered DLTs.
  • Number of Patients With Toxicities [ Time Frame: Up to 1 year ]
    Toxicities was evaluated based on the standard NCI CTCAE Version 3.0 grading criteria. Attributable grade ≥ 3 hematologic and non-hematologic toxicities are presented here.
  • Safety (phase I)
  • Efficacy, as measured by objective tumor response rate (phase II)
Complete list of historical versions of study NCT00470548 on ClinicalTrials.gov Archive Site
  • Duration of Overall Survival [ Time Frame: Up to 2 years ]
    From time of enrollment to the first observation of disease progression or death.
  • Number of Participants With Complete Response [ Time Frame: Up to 2 years ]
    Per RECIST criteria, complete response (CR) is defined as the disappearance of all target lesions.
  • Number of Participants With Stable Disease [ Time Frame: Up to 2 years ]
    Stable Disease is measured from the start of the treatment until the criteria for disease progression are met. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
  • Number of Participants With Partial Response [ Time Frame: Up to 2 years ]
    At least a 30% decrease in the sum of the longest diameter of target lesions
  • Number of Participants With Disease Control [ Time Frame: Up to 2 years ]
    Disease control is complete response plus partial response plus stable disease from the start of treatment to death or disease progression.
  • Maximum tolerated dose (phase I)
  • Progression-free survival (phase II)
  • Overall survival (phase II)
Not Provided
Not Provided
 
Abraxane and Alimta in Advanced Solid Tumors
Phase I/II Trial of Abraxane® (ABI-007) and Alimta® (Pemetrexed) in Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with pemetrexed may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see how well they work in treating patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors.

OBJECTIVES:

Primary

  • Determine the safety of paclitaxel albumin-stabilized nanoparticle formulation when administered with pemetrexed disodium in patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors. (Phase I)
  • Determine the efficacy of this regimen, as measured by objective tumor response rate (RECIST criteria), in these patients. (Phase II)

Secondary

  • Determine the preliminary efficacy of paclitaxel albumin-stabilized nanoparticle formulation and pemetrexed disodium in these patients. (Phase I)
  • Determine the overall survival of patients treated with this regimen. (Phase II)
  • Evaluate the frequency and severity of toxicities associated with this regimen. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by an open-label, phase II study.

  • Phase I: Patients receive pemetrexed disodium IV over 10 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive pemetrexed disodium and paclitaxel albumin-stabilized nanoparticle formulation at the MTD as in phase I.

After completion of study treatment, patients are followed periodically.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Lung Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: Abraxane
    ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)
    Other Names:
    • paclitaxel albumin-stabilized nanoparticle formulation
    • ABI-007
  • Drug: Alimta
    Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)
    Other Name: pemetrexed disodium
  • Experimental: Phase I: Abraxane and Alimta
    Three dose levels were tested. Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 180, 220, and 260 mg/m2 every 21 days.
    Interventions:
    • Drug: Abraxane
    • Drug: Alimta
  • Experimental: Phase II: Abraxane and Alimta
    Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 260 mg/m2 every 21 days.
    Interventions:
    • Drug: Abraxane
    • Drug: Alimta
Ho C, Davies AM, Sangha RS, Lau D, Lara P Jr, Chew HK, Beckett L, Mack PC, Riess JW, Gandara DR. Phase I/II trial of pemetrexed plus nab-paclitaxel in advanced solid tumor patients with emphasis on non-small cell lung cancer. Invest New Drugs. 2013 Dec;31(6):1587-91. doi: 10.1007/s10637-013-0024-y. Epub 2013 Sep 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
49
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. For the phase II portion patients must have cytologically or histologically proven selected stage IIIB (pleural effusion) or IV NSCLC.
  2. For the phase II portion patients must have NSCLC that has progressed or recurred after treatment with platinum-based therapy.
  3. No prior pemetrexed. Prior Taxol is allowed. Prior ABI 007 is not allowed.
  4. Patients must have measurable disease by RECIST criteria for the phase II portion.
  5. Patients must be 18 years of age or older.
  6. Patients must have a performance status of 0 -2
  7. Patients must have an estimated survival of at least 3 months.
  8. Any prior chemotherapy must have been completed at least 4 weeks prior to start of treatment.
  9. Patients must have adequate renal function as documented by a calculated creatinine clearance of > 45 ml/min
  10. Patients must have adequate liver functions: AST and ALT < 2.5 X upper limit of normal, and bilirubin < upper limit of normal.
  11. Patients must have adequate bone marrow function: Platelets >100,000 cells/mm3 and ANC > 1,500 cells/mm3.
  12. For patients who have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before initiation of pemetrexed therapy, consideration should be given to draining the effusion prior to dosing.
  13. Patients with asymptomatic treated brain metastasis (surgical resection or radiotherapy) may be included if they are neurologically stable and have been off steroids and anticonvulsants for at least 4 weeks.
  14. Patients must be able to take and retain oral medication.
  15. Ability to take folic acid, vitamin B12 and dexamethasone according to protocol.
  16. Ability to interrupt NSAIDS 2 days before, the day of, and 2 days following administration of pemetrexed.
  17. Patients of reproductive potential must agree to use effective contraceptive method while on treatment and for 3 months afterwards as the effects of these drugs on the unborn fetus are unknown.
  18. No other current active malignancy.
  19. Patient or his/her legally authorized representative or guardian signed the Informed Consent form prior to participation in any study-related activities.

Exclusion Criteria

  1. Pregnant or breastfeeding women.
  2. Patient with pre-existing peripheral neuropathy of NCI CTCAE Version 3.0 of grade 2.
  3. Patient has a clinically significant concurrent illness.
  4. Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered.
  5. Patient has a history of allergy or hypersensitivity to the study drugs or a taxane.
  6. Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
  7. Prior therapy with pemetrexed, or ABI-007.
  8. Patient is receiving treatment with any excluded concomitant medication.
  9. Presence of third space fluid which cannot be controlled by drainage.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00470548
UCDCC#185
H3E-US-I017 ( Other Grant/Funding Number: Eli Lilly )
ABX027 ( Other Grant/Funding Number: Celgene )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
University of California, Davis
University of California, Davis
  • Celgene
  • Eli Lilly and Company
Study Chair: David R. Gandara, MD University of California, Davis
University of California, Davis
May 2017

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