Trial Outcomes & Findings for Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma (NCT NCT00073983)

Last Updated: 2012-03-12

Results Overview

Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days

Results posted on

2012-03-12

Participant Flow

Recruitment period began October 4, 2006 and was completed May 12, 2009. There were 11 SARC (Sarcoma Alliance for Research through Collaboration) sites participating. SARC sites are primarily academic institutions with Sarcoma programs.

Participant milestones

Participant milestones
Measure	Combination Chemotherapy Gemcitibine 675 mg/m\^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m\^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
Overall Study STARTED	54
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination Chemotherapy Gemcitibine 675 mg/m\^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m\^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
Overall Study not evaluable	1

Baseline Characteristics

Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Chemotherapy n=54 Participants Gemcitibine 675 mg/m\^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m\^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age Continuous	43 years STANDARD_DEVIATION 19 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants

PRIMARY outcome

Timeframe: After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days

Population: Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.

Outcome measures

Outcome measures
Measure	Ewing's Sarcoma n=14 Participants Combination chemotherapy	Osteosarcoma n=14 Participants Combination Chemotherapy	Chondrosarcoma n=25 Participants Combination chemotherapy
Objective Response Rate	6 participants	5 participants	14 participants

SECONDARY outcome

Timeframe: post-cycle 2, 4, 8 and 12

Population: Analysis not completed. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.

Stable disease is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started. The clinical relevance of the duration of stable disease varies for different tumor types and grades. Bayesian statistical model is used. Timepoints for evaluation are post-cycle 2, 4, 8 and 12 using RECIST 1.0 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout the study

Population: Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.

Toxicity was graded according to Common Terminology Criteria for Adverse Events v.3.0 (CTCAE v.3.0). For gemcitabine or docetaxel related grade 3 or 4 non-hematological toxicities or hematological toxicities (grade 3 or 4 neutropenia for ≥ 7 days, grade 4 thrombocytopenia, or any platelet transfusion), both agents were withheld until the toxicity was ≤ grade 1. If the toxicity recovered to ≤ grade 1 by cycle day 35, the dose of both agents was reduced for all subsequent cycles. If the toxicity did not resolve by day 35, protocol therapy was discontinued.

Outcome measures

Outcome measures
Measure	Ewing's Sarcoma n=14 Participants Combination chemotherapy	Osteosarcoma n=14 Participants Combination Chemotherapy	Chondrosarcoma n=25 Participants Combination chemotherapy
Toxicity as Assessed by NCI CTCAE v3.0 Toxicity	4 participants	3 participants	5 participants
Toxicity as Assessed by NCI CTCAE v3.0 No Toxicity	10 participants	11 participants	20 participants

SECONDARY outcome

Timeframe: Gemcitibine: 0hr, 75, 85, 95, 105 and 120 min after the start of the 90 minute infusion; docetaxel: 0hr, 55 min, 30 min post infusion, 5hr and 24hr post infusion.

Population: There were insufficent samples obtained to analyze pharmacokinetics.

Blood samples for the determination of gemcitabine (and its metabolite dFdU) will be obtained prior to infusion, at 75 and 85 minutes (steady state), and 95 105 and 120 minutes, after the start of the 90 minute infusion on day 1 and day 8 of cycle 1. On day 8, docetaxel pharmacokinetics will be performed prior to infusion, 55 minutes (5 minutes prior to the end of infusion), 30 minutes post infusion, 5 hr and 24hr post infusion.

Outcome measures

Outcome data not reported

Adverse Events

Combination Chemotherapy

Serious events: 12 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combination Chemotherapy n=53 participants at risk Gemcitibine 675 mg/m\^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m\^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
Skin and subcutaneous tissue disorders cellulitis	3.8% 2/53 • Number of events 3 • 4 years, 9 months
Infections and infestations fever	5.7% 3/53 • Number of events 3 • 4 years, 9 months
Respiratory, thoracic and mediastinal disorders shortness of breath	5.7% 3/53 • Number of events 3 • 4 years, 9 months
Blood and lymphatic system disorders elevated WBC	1.9% 1/53 • Number of events 1 • 4 years, 9 months
Infections and infestations pneumonia	5.7% 3/53 • Number of events 3 • 4 years, 9 months
Respiratory, thoracic and mediastinal disorders hypoxia	1.9% 1/53 • Number of events 1 • 4 years, 9 months
Respiratory, thoracic and mediastinal disorders pneumonitis	3.8% 2/53 • Number of events 2 • 4 years, 9 months
Musculoskeletal and connective tissue disorders back pain	1.9% 1/53 • Number of events 1 • 4 years, 9 months
Musculoskeletal and connective tissue disorders myositis	1.9% 1/53 • Number of events 1 • 4 years, 9 months
Blood and lymphatic system disorders anemia	1.9% 1/53 • Number of events 1 • 4 years, 9 months
Nervous system disorders confusion	1.9% 1/53 • Number of events 1 • 4 years, 9 months
Infections and infestations sepsis	1.9% 1/53 • Number of events 1 • 4 years, 9 months
Cardiac disorders pericardial effusion	1.9% 1/53 • Number of events 1 • 4 years, 9 months
Cardiac disorders cardiac tamponade	1.9% 1/53 • Number of events 1 • 4 years, 9 months
Cardiac disorders chest pain	1.9% 1/53 • Number of events 1 • 4 years, 9 months
Respiratory, thoracic and mediastinal disorders hemoptysis	1.9% 1/53 • Number of events 1 • 4 years, 9 months

Other adverse events

Other adverse events
Measure	Combination Chemotherapy n=53 participants at risk Gemcitibine 675 mg/m\^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m\^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
Blood and lymphatic system disorders Grade 4 hematologic	26.4% 14/53 • Number of events 24 • 4 years, 9 months
Blood and lymphatic system disorders Grade 3 hematologic	41.5% 22/53 • Number of events 58 • 4 years, 9 months

Additional Information

SARC Chief Operating Officer

SARC

Phone: 734-930-7600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60