A Trial of Doxil and Multiday Vinorelbine in Patients With Metastatic Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Hematology Oncology Consultants
Updated on 7 November 2020
platelet count
measurable disease
breast cancer
metastasis
neutrophil count
advanced breast cancer
vinorelbine

Summary

This is a phase II trial of Doxil on day 1 and vinorelbine on days 1 and 2 in women with metastatic breast cancer. Administered every 28 days. A study to assess the safety and efficacy of Doxil and vinorelbine in metastatic breast cancer.

Description

PROTOCOL SUMMARY Study design: Phase II trial of monthly Doxil® and vinorelbine on day 1 and 2 in women with metastatic breast cancer. Treatment plan: Patients will continue therapy, until they have unacceptable toxicity or disease progression. Primary endpoint: Response rate Secondary endpoints: Time to progression, overall survival and toxicity. Additional study objectives: Evaluation of treatment-related dyspnea, with measurement of pulse oximetry during and after drug administration, and rigorous study of patients who experience dyspnea. Palmar-plantar erythrodysesthesia (PPE) will be treated with one of 2 randomly assigned topical salves, measuring duration and severity of symptoms. Eligibility: Women who have had prior chemotherapy in the adjuvant or metastatic setting, or both, up to 3 prior regimens. Patients having more than one prior regimen for metastatic disease must have a performance status of 0 or 1; others may have 0-2. No prior Doxil® or vinorelbine therapy. Patients are ineligible if prior anthracycline dose is greater than 400 mg/m2, or if they have primary anthracycline-refractory disease, with disease progression during treatment or with relapse/recurrence within 6 months after last dose of anthracycline. Patients must have normal neurologic, hematologic, renal and hepatic functional parameters. Asymptomatic brain metastases are permissible. Treatment plan: Doxil® 40 mg/m2 IV infusion over 60 minutes on day 1 Vinorelbine 15 mg/m2 IV over 6 minutes on days 1 and 2 Dexamethasone 4 mg IV or 8 mg po (Doxil® pretreatment) Heparin 5000 U IV (Vinorelbine pretreatment) Pyridoxine (vitamin B6) 200 mg po qd Repeat every 28 days. Supportive measures: For anemia (hematocrit < 35): Procrit® 40,000 U q wk For neutropenia (ANC < 1,000/mm3 ): Prophylactic antibiotics (Cipro® or Septra®) For all cycles after neutropenic fever/infection or grade 3-4 stomatitis: Prophylactic Neulasta® 6 mg SQ on day 3 (This intervention may be adopted for all patients, all cycles, if 2 of the first 4 patients enrolled need it.) For PPE: randomize between 2 topical salves and document duration and severity of sx Dose adjustments: Subsequent cycles are given on day 29 or after recovery or to grade 0-1 toxicity, with no more than 3 weeks delay. Reduce dose of both drugs by 25% if grade 3 or 4 stomatitis or palmar-plantar or grade 4 thrombocytopenia. Reduce dose of Doxil® ONLY by 50-75% if abnormal bilirubin, alkaline phosphatase and/or ALT, AST (appendix 14.3)

Details
Treatment Doxil and Vinorelbine
Clinical Study IdentifierNCT00159094
SponsorHematology Oncology Consultants
Last Modified on7 November 2020

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note