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Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Early- Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (RECOVER)

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ClinicalTrials.gov Identifier: NCT02953340
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Brief Summary:
The purpose of this study is to compare the efficacy of SPI-2012 with pegfilgrastim in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) to prevent and reduce Neutropenia that is associated with cancer chemotherapy.

Condition or disease Intervention/treatment Phase
Neutropenia Breastcancer Drug: SPI-2012 Drug: Pegfilgrastim Drug: Docetaxel Drug: Cyclophosphamide Phase 3

Detailed Description:

This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 with pegfilgrastim in breast cancer patients treated with TC chemotherapy to prevent and reduce Neutropenia.

Approximately 218 patients will be enrolled and randomized in a 1:1 ratio to 2 treatment arms:

Each cycle will be 21 days. Total 4 cycles will be evaluated for this study. On Day 1 of each cycle, patients will receive TC chemotherapy. On Day 2 of each cycle, patients will received study drug (SPI-2012 or pegfilgrastim).

After cycle 1, as applicable, patients who have received at least one dose of study drug will be followed for 12 months after the last dose of study treatment for safety.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
Experimental: Docetaxel +Cyclophosphamide+ SPI-2012
  • SPI-2012 (13.2 mg/0.6 mL fixed dose, equivalent to 3.6)
  • Supplied in prefilled single-use syringes for subcutaneous injection
  • Administered on Day 2 of each cycle
Drug: SPI-2012
Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
Other Name: Eflapegrastim

Drug: Docetaxel
75mg/m^2 IV infusion administered on Day 1 of each cycle
Other Name: Taxotere

Drug: Cyclophosphamide
600mg/m^2 IV infusion administered on Day 1 of each cycle
Other Name: Cytoxan

Active Comparator: Docetaxel +Cyclophosphamide+ Pegfilgrastim
  • Pegfilgrastim (6 mg/0.6 mL) (Neulasta®)
  • Single-dose subcutaneous injection on Day 2 of each cycle.
Drug: Pegfilgrastim
Subcutaneous injection administered on Day 2 of each cycle.
Other Name: Neulasta®

Drug: Docetaxel
75mg/m^2 IV infusion administered on Day 1 of each cycle
Other Name: Taxotere

Drug: Cyclophosphamide
600mg/m^2 IV infusion administered on Day 1 of each cycle
Other Name: Cytoxan




Primary Outcome Measures :
  1. Duration of severe neutropenia (DSN) in Cycle 1 [ Time Frame: Up to 21 days ]
    DSN is defined as the number of days of severe neutropenia, Absolute Neutrophil Count (ANC <0.5×10^9/L) from the first occurrence of an ANC below the threshold.


Secondary Outcome Measures :
  1. Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 [ Time Frame: Up to 21 days ]
  2. Depth of ANC Nadir, defined as the patient's lowest ANC in Cycle 1 [ Time Frame: Up to 21 days ]
  3. Incidence of Febrile Neutropenia (FN) in patients during Cycle 1 [ Time Frame: Up to 21 days ]
    FN will be evaluated through daily temperature monitoring to assess for fever and frequent CBCs to assess for neutropenia.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer.
  • Candidate to receive adjuvant or neo-adjuvant TC chemotherapy.
  • ECOG ≤2.
  • ANC ≥1.5×10^9/L.
  • Platelet count ≥100×10^9/L.
  • Hemoglobin >9 g/dL.
  • Calculated creatinine clearance > 50 mL/min.
  • Total bilirubin ≤1.5 mg/dL.
  • AST/SGOT and ALT/SGPT ≤2.5×ULN. (upper limit of normal)
  • Alkaline phosphatase ≤2.0×ULN.

Key Exclusion Criteria:

  • Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease.
  • Known sensitivity to E. coli derived products.
  • Concurrent adjuvant cancer therapy.
  • Locally recurrent/metastatic.
  • Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug.
  • Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
  • Prior bone marrow or stem cell transplant.
  • Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
  • Prior radiation therapy within 30 days prior to enrollment.
  • Major surgery within 30 days prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953340


Contacts
Contact: Helen Vu 949-743-9395 spi-gcf-302@sppirx.com
Contact: Sanjay Mourya 949-743-9322

Locations
United States, Mississippi
Jackson Oncology Associates, PLLC Recruiting
Jackson, Mississippi, United States, 39202
Contact: Tammy Young         
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02953340     History of Changes
Other Study ID Numbers: SPI-GCF-302
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Spectrum Pharmaceuticals, Inc:
Neutropenia
Breast Cancer
Long-acting Myeloid Growth Factor
Early Stage Breast Cancer
Docetaxel + Cyclophosphamide (TC) chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Cyclophosphamide
Docetaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators