Trial Outcomes & Findings for Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer (NCT NCT00063934)

NCT ID: NCT00063934

Last Updated: 2019-03-05

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: From baseline until the date of first documented toxicity or date of death from any cause, whichever came first, assessed every three weeks up to 2 years and 5 months
• Results posted on: 2019-03-05

Participant Flow

Recruitment Period: May 16, 2003 to August 25, 2005; All recruited at UT MD Anderson Cancer Center.

Of the 31 participants enrolled, one participant was ineligible for treatment.

Participant milestones

Measure	Oblimersen Plus Doxorubicin + Docetaxel Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m\^2 and Docetaxel 75 mg/m\^2 infused on Day 6
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Oblimersen Plus Doxorubicin + Docetaxel Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m\^2 and Docetaxel 75 mg/m\^2 infused on Day 6
Overall Study Ineligible	1

Baseline Characteristics

Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer

Baseline characteristics by cohort

Measure	Neoadjuvant G3139, Doxorubicin and Docetaxel n=31 Participants Patients with locally advanced breast cancer received intravenous G3139 in combination with doxorubicin and docetaxel . Cycles were repeated every 21 days x 6.
Age, Continuous	49 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline until the date of first documented toxicity or date of death from any cause, whichever came first, assessed every three weeks up to 2 years and 5 months

Outcome measures

Measure	Oblimersen Plus Doxorubicin + Docetaxel n=30 Participants Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m\^2 and Docetaxel 75 mg/m\^2 infused on Day 6
Number of Participant With Toxicities	30 Participants

PRIMARY outcome

Timeframe: At time of definitive surgery (after 6 courses of neoadjuvant therapy in 3 week cycles), approximately 18 weeks

Population: Intention to treat eligible participants per protocol.

Pathologic complete responses (pCR), defined as no evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes, measured by microscopic evaluation of tissue specimen at time of definitive surgery (after 6 courses of neoadjuvant therapy). Neoadjuvant (preoperative) therapy administered on the first five days of every 3-week cycle. Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]

Outcome measures

Measure	Oblimersen Plus Doxorubicin + Docetaxel n=30 Participants Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m\^2 and Docetaxel 75 mg/m\^2 infused on Day 6
Number of Participants With Pathologic Complete Response (pCR)	0 Participants

SECONDARY outcome

Timeframe: After 3 and 6 courses of 21 day treatments (up to 18 weeks)

Evaluation target lesions (clinical response) by physical exam/ultrasound measurements of primary tumor and axillary lymph nodes after 3-6 courses: Complete Response: Disappearance of all target lesions; Partial Response: >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1>new lesions; Stable Disease: Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum LD since treatment started.

Outcome measures

Measure	Oblimersen Plus Doxorubicin + Docetaxel n=30 Participants Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m\^2 and Docetaxel 75 mg/m\^2 infused on Day 6
Clinical Imaging Responses CR	30 participants
Clinical Imaging Responses PR	0 participants

SECONDARY outcome

Timeframe: before treatment and at 3-5 days after oblimersen treatment

Number of participant with Bcl-2 Expression in breast cancer tissue by protein and mRNA expression before treatment and at 3-5 days after oblimersen treatment.

Outcome measures

Measure	Oblimersen Plus Doxorubicin + Docetaxel n=30 Participants Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m\^2 and Docetaxel 75 mg/m\^2 infused on Day 6
Bcl-2 Expression in Breast Cancer Tissue	30 participants

Adverse Events

Oblimersen Plus Doxorubicin + Docetaxel

Serious events: 30 serious events

Other events: 30 other events

Deaths: 1 deaths

Serious adverse events

Measure	Oblimersen Plus Doxorubicin + Docetaxel n=30 participants at risk Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m\^2 and Docetaxel 75 mg/m\^2 infused on Day 6
Infections and infestations Infection, non-neutropenia	6.7% 2/30 • Number of events 2 • 2 years and 5 months
Musculoskeletal and connective tissue disorders Myalgia	10.0% 3/30 • Number of events 3 • 2 years and 5 months
Blood and lymphatic system disorders Neutropenia	23.3% 7/30 • Number of events 7 • 2 years and 5 months
Blood and lymphatic system disorders Anemia	13.3% 4/30 • Number of events 4 • 2 years and 5 months
Metabolism and nutrition disorders Thrombocytopenia	13.3% 4/30 • Number of events 4 • 2 years and 5 months
Infections and infestations Infection or fever with Neutropenia	10.0% 3/30 • Number of events 3 • 2 years and 5 months
Gastrointestinal disorders Diarrhea	3.3% 1/30 • Number of events 1 • 2 years and 5 months
Endocrine disorders Fatigue	70.0% 21/30 • Number of events 21 • 2 years and 5 months
Cardiac disorders Death	3.3% 1/30 • Number of events 1 • 2 years and 5 months

Other adverse events

Measure	Oblimersen Plus Doxorubicin + Docetaxel n=30 participants at risk Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m\^2 and Docetaxel 75 mg/m\^2 infused on Day 6
Gastrointestinal disorders Diarrhea	30.0% 9/30 • Number of events 9 • 2 years and 5 months
General disorders Drug fever	36.7% 11/30 • Number of events 11 • 2 years and 5 months
General disorders Fatigue	30.0% 9/30 • Number of events 9 • 2 years and 5 months
Gastrointestinal disorders Heartburn/Dyspepsia	6.7% 2/30 • Number of events 2 • 2 years and 5 months
Gastrointestinal disorders Nausea	93.3% 28/30 • Number of events 28 • 2 years and 5 months
Eye disorders Ocular/Vision (other)	6.7% 2/30 • Number of events 2 • 2 years and 5 months
Skin and subcutaneous tissue disorders Pruritis/Itching	6.7% 2/30 • Number of events 2 • 2 years and 5 months
Skin and subcutaneous tissue disorders Rash/Desquamation	20.0% 6/30 • Number of events 6 • 2 years and 5 months
Nervous system disorders Sensory Neuropathy	10.0% 3/30 • Number of events 3 • 2 years and 5 months
Gastrointestinal disorders Stomatitis	16.7% 5/30 • Number of events 5 • 2 years and 5 months
Gastrointestinal disorders Vomiting	40.0% 12/30 • Number of events 12 • 2 years and 5 months
Hepatobiliary disorders Alanine aminotransferase	26.7% 8/30 • Number of events 8 • 2 years and 5 months
Infections and infestations Neutropenia	10.0% 3/30 • Number of events 3 • 2 years and 5 months
Blood and lymphatic system disorders Anemia	70.0% 21/30 • Number of events 21 • 2 years and 5 months
Blood and lymphatic system disorders Thrombocytopenia	20.0% 6/30 • Number of events 6 • 2 years and 5 months

Additional Information

Francisco Esteva, MD, PHD / Professor

UTMDACC

Phone: 713-792-2817

Email: Francisco.Esteva@nyumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60