Gemcitabine Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines and/or Taxanes

NCT00192101 | Completed Phase 2

• 2 other identifiers: 9590B9E-SI-S371
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, two arms, randomized, unblinded phase 2 study in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen in the adjuvant/neoadjuvant or 1st line metastatic setting. Gemcitabine will be administered via intravenous infusion over approximately 30 minutes at a dose of 1250mg/m2 on days 1 and 8 of each 21-day cycle. In arm A:Cisplatin will be given via intravenous infusion over approximately 60-120 minutes at a dose of 70 mg/m2 on Day 1 of each 21-day cycle. The investigator may attempt to give Cisplatin with at least one liter of fluids for hydration and on an outpatient basis. Patients will remain in the study until disease progression or when a maximum of six cycles have been administered. Study therapy may continue until:

• There is evidence of progressive disease
• The patient experiences unacceptable toxicity.
• The investigator decides that the patient should be discontinued.
• The patient requests discontinuation
• The patient has received 6 cycles of the regimen (if the physician decides to continue after 6 cycles-this will be done after consultation with the sponsor)
• Discontinuation from study therapy is indicated according to the additional guidelines described in the protocol After patients discontinue from study therapy, they proceed to the post-study follow up phase of the study.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Overall response rates of the combination of gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline with/without taxane based regimen

• in the adjuvant/neoadjuvant or 1st line metastatic setting for each treatment arm separately.

Secondary Outcomes (3)

• To characterize the quantitative and qualitative toxicity of gemcitabine-cisplatin patient population for each treatment arm separately;Relative dose intensity of gemcitabine and cisplatin for each treatment arm separately

• Rate of dose modifications (omissions, reductions, delays) for each treatment arm separately;Time to progression for each treatment arm separately;Duration of response for each treatment arm separately;1-year survival in each treatment arm separately

• Overall survival in each treatment arm separately;To assess the medical resources utilization with the combination in each treatment arm separately

Interventions

gemcitabine DRUG

cisplatin DRUG

Eligibility Criteria

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

You may qualify if:

• Histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. Lesions should not be amenable to surgery or radiation of curative intent.
• Presence of metastatic or local-regional recurrent disease, according to the American Joint Committee on Cancer
• Uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (CT), Chest x-ray or clinical examination, according to RECIST criteria
• Patients with unresectable, locally recurrent or metastatic breast cancer who, were pre-treated with anthracyclines with/without taxanes (paclitaxel, docetaxel)containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study. Prior chemotherapy has to be terminated 4 weeks prior. Study randomization and disease progression under this therapy has to be documented, also patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
• Prior radiotherapy must be completed at least 30 days before study entry. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment (except for alopecia). Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.

You may not qualify if:

• Have received treatment within the last 30 days with an investigational drug for any indication before study entry.
• Concurrent administration of other tumor therapy, including cytotoxic chemotherapy, surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including Herceptin)
• Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy, unless adequately treated.
• Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment(except in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2004
• Study Completion: July 1, 2005
• Last Updated: November 20, 2007

Record last verified: 2007-11

Locations

SA (1)