Trial Outcomes & Findings for Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer (NCT NCT00227721)
NCT ID: NCT00227721
Last Updated: 2020-12-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).
Results posted on
2020-12-02
Participant Flow
Participant milestones
| Measure |
Docetaxel & Gemcitabine Hydrochloride
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Docetaxel & Gemcitabine Hydrochloride
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
|
|---|---|
|
Overall Study
On study, but never treated.
|
1
|
Baseline Characteristics
Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel & Gemcitabine Hydrochloride
n=29 Participants
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
|
|---|---|
|
Age, Continuous
|
57.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).Outcome measures
| Measure |
Docetaxel & Gemcitabine Hydrochloride
n=29 Participants
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
|
|---|---|
|
Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.
|
62 percentage of participants with CR or PR
Interval 47.0 to 75.0
|
SECONDARY outcome
Timeframe: Every two cycles until disease progression or death, assessed up to 5 yearsProgression-free survival estimated using Kaplan-Meier's product-limit method.
Outcome measures
| Measure |
Docetaxel & Gemcitabine Hydrochloride
n=30 Participants
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
|
|---|---|
|
Progression-free Survival
|
7.2 months
Interval 0.03 to 28.9
|
Adverse Events
Docetaxel & Gemcitabine Hydrochloride
Serious events: 14 serious events
Other events: 24 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Docetaxel & Gemcitabine Hydrochloride
n=29 participants at risk
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
|
|---|---|
|
Investigations
Absolute neutrophil count (ANC)
|
48.3%
14/29 • Number of events 14 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
White Blood Count (WBC)
|
34.5%
10/29 • Number of events 10 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
Platelets
|
24.1%
7/29 • Number of events 7 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
General disorders
Fatigue
|
20.7%
6/29 • Number of events 6 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
Hemoglobin (HGB)
|
10.3%
3/29 • Number of events 3 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
General disorders
Pain
|
10.3%
3/29 • Number of events 3 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.3%
3/29 • Number of events 3 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Diarrhea
|
6.9%
2/29 • Number of events 2 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Number of events 2 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Infections and infestations
Infection w/o Neutropenia
|
6.9%
2/29 • Number of events 2 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
Elevated Aspartate aminotransferase (AST)
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
Elevated total bilirubin
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Metabolism and nutrition disorders
Abnormal magnesium
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Respiratory, thoracic and mediastinal disorders
Fluid Retention Syndrome
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Ileus
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Metabolism and nutrition disorders
Anorexia
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Ascites
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Mucositis
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Renal and urinary disorders
Hydronephrosis
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Skin and subcutaneous tissue disorders
Abnormal electrolytes
|
3.4%
1/29 • Number of events 1 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
Other adverse events
| Measure |
Docetaxel & Gemcitabine Hydrochloride
n=29 participants at risk
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
|
|---|---|
|
Infections and infestations
Absolute neutrophil count (ANC)
|
31.0%
9/29 • Number of events 9 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Blood and lymphatic system disorders
WBC
|
51.7%
15/29 • Number of events 15 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Blood and lymphatic system disorders
Platelets
|
51.7%
15/29 • Number of events 15 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
General disorders
Fatigue
|
72.4%
21/29 • Number of events 21 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
Hemoglobin (HGB)
|
82.8%
24/29 • Number of events 24 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
General disorders
Pain
|
55.2%
16/29 • Number of events 16 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
34.5%
10/29 • Number of events 10 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Diarrhea
|
31.0%
9/29 • Number of events 9 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Vomiting
|
17.2%
5/29 • Number of events 5 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Nausea
|
44.8%
13/29 • Number of events 13 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
Elevated aspartate aminotransferase (AST)
|
20.7%
6/29 • Number of events 6 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
Elevated total bilirubin (hyperbilirubinemia)
|
10.3%
3/29 • Number of events 3 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Metabolism and nutrition disorders
Abnormal magnesium
|
17.2%
5/29 • Number of events 5 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Bloating
|
6.9%
2/29 • Number of events 2 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Blood and lymphatic system disorders
Hemorrhage
|
13.8%
4/29 • Number of events 4 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
General disorders
Fever
|
10.3%
3/29 • Number of events 3 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Gastrointestinal disorders
Constipation
|
44.8%
13/29 • Number of events 13 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
Elevated Alanine Aminotransferase (ALT)
|
24.1%
7/29 • Number of events 7 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
Elevated creatinine/bun
|
17.2%
5/29 • Number of events 5 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Nervous system disorders
Sensory Neuropathy
|
62.1%
18/29 • Number of events 18 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Investigations
Albumin
|
6.9%
2/29 • Number of events 2 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Metabolism and nutrition disorders
Glucose
|
6.9%
2/29 • Number of events 2 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
34.5%
10/29 • Number of events 10 • From enrollment up to progression, death, or five years (whichever occurred first).
30 patients were consented but one was never treated with any drug. Therefore, all AEs are from the 29 treated patients but the all-cause mortality is from all patients (intend to treat).
|
Additional Information
Robert Morris, M.D.
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-9436
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place