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A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage IV (Metastatic) Breast Cancer

Intervention: ABI-007 (Drug); vinorelbine (Drug); Trastuzumab (Drug); G-CSF (Biological)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Celgene Corporation

Summary

The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive disease may receive Herceptin, and 2) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the presence of planned growth factor support with G-CSF.

Clinical Details

Official title: An Open-Label Phase I/II Study of Weekly ABI-007 and Vinorelbine With or Without G-CSF in Patients With Stage IV (Metastatic) Breast Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Participants With Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)

Participants With Dose Limiting Toxicities

Percentage of Participants With Discontinued, Delayed or Interrupted Therapy

Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC), White Blood Cell (WBC), Platelet, and Hemoglobin Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)

Nadir Measurement for Absolute Neutrophil (ANC), White Blood Cell (WBC) and Platelet Count

Nadir Measurement for Hemoglobin (Hgb)

Secondary outcome:

Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)

Kaplan Meier Estimate for Time to Disease Progression (TTP)

Kaplan-Meier Estimate for Duration of Response

Kaplan Meier Estimate for Progression-Free Survival (PFS)

Kaplan-Meier Estimates for Participant Survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient has microscopically confirmed invasive breast carcinoma with clinical

and/or radiographic evidence of stage 4 disease. If diagnosis is based on pleural effusion, positive cytology must be confirmed.

- Patient has had no prior chemotherapy for Stage 4 disease (hormone therapy is

permitted). Prior adjuvant paclitaxel by 3-hour infusion is permitted, if there is no residual neuropathy. Prior adjuvant docetaxel on an every 3 week schedule is permitted.

- Disease must be measurable (unidimensional by Response Evaluation Criteria In Solid

Tumors (RECIST) criteria) or evaluable (e. g., malignant effusion, marrow involvement). Elevated tumor markers alone are insufficient.

- Age >18.

- Southwest Oncology Group (SWOG)/Eastern Oncology Group (ECOG) performance status must

be < or =2 at screen and on treatment day one.

- Life expectancy must be estimated at >16 weeks.

- Prior irradiation is permitted, provided:

- Does not exceed 25% of the estimated bone marrow volume

- Measurable/evaluable disease exists outside the radiation field, or progressive

disease is documented within the radiation field.

- Informed consent must be obtained prior to registration.

- Patients must be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to

the pelvis, spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin C or nitrosureas), or > 2 weeks from prior hormonal therapy.

- All patients must have placement of appropriate central venous access device.

- Tumor HER2/neu expression must be determined prior to study enrollment. Assessment

may be by fluorescence in situ hybridization (FISH) assay or by immunohistochemistry (ICC). If determination is intermediate by ICC, FISH must be performed. For enrollment purposes, this phase I study will not discriminate based on HER2 status. However, documentation of patients' HER2 status will be maintained and Herceptin will be prescribed for all HER2 positive patients. Exclusion Criteria:

- Granulocytes < 1,500/mm^3.

- Platelets < 100,000/mm^3.

- Hemoglobin < 9 gm/dl.

- Creatinine > 2. 0 mg/dl.

- Total bilirubin > 2 mg/dl.

- Visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung

metastases.

- Medically unstable as judged by the patient's physician.

- Pregnancy or lactation; failure to employ adequate contraception.

- Uncontrolled central nervous system (CNS) disease.

- Pre-existing Grade ≥ 2 peripheral neuropathy except for abnormalities due to cancer.

- Psychological, familial, sociological or geographical conditions which do not permit

weekly medical follow-up and compliance with the study protocol.

- Prior therapy with vinorelbine or prior therapy with a taxane that resulted in

neuropathy.

Locations and Contacts

City of Hope Comprehensive Cancer Care Center, Duarte, California 91010, United States

Seattle Cancer Care Alliance, Seattle, Washington 98109, United States

Additional Information

Starting date: August 2005
Last updated: August 20, 2013

Page last updated: August 23, 2015

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