Trial Outcomes & Findings for Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma (NCT NCT00504257)

Last Updated: 2014-02-06

Results Overview

Percentage of participants with PFS at six months. PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

6 months per participant

Results posted on

2014-02-06

Participant Flow

Between March 2007 and February 2011, 45 patients were screened.

Participant milestones

Participant milestones
Measure	Avastin and Docetaxel Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Overall Study STARTED	45
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Avastin and Docetaxel Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Overall Study Withdrawal by Subject	2
Overall Study ineligible histology	2

Baseline Characteristics

Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avastin and Docetaxel n=41 Participants Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=93 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants
Age, Continuous	58.2 years n=93 Participants
Sex: Female, Male Female	41 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	41 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months per participant

Population: All evaluable participants

Outcome measures

Outcome measures
Measure	Avastin and Docetaxel n=41 Participants Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Six Month Progression Free Survival (PFS)	43.9 percentage of participants Interval 28.6 to 58.2

SECONDARY outcome

Timeframe: Up to 5 years

Population: All evaluable participants

PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Avastin and Docetaxel n=41 Participants Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Median Progression Free Survival	5.2 months Interval 4.4 to 7.2

SECONDARY outcome

Timeframe: Up to 5 years

Population: Response Rate (RR) evaluable patients included all patients who received at least 2 cycles of treatment and at least one tumor assessment or had demonstrated clinical progression.

Overall Response: Complete Response (CR) + Partial Response (PR). To determine the response rate (RR) of the investigational treatment regimen. Response and progression were evaluated in the study by using the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) method or modified Rustin Criteria for CA-125 measurements.

Outcome measures

Outcome measures
Measure	Avastin and Docetaxel n=38 Participants Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Overall Response Rate (RR)	22 participants

SECONDARY outcome

Timeframe: Up to 4 years

Population: All evaluable participants

Number of participants with Grade 3 or 4 Toxicity based on 278 treatment cycles. Toxicity was graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Outcome measures
Measure	Avastin and Docetaxel n=41 Participants Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Occurrence of Grade 3 or 4 Toxicity	27 participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: All evaluable participants

Overall Survival (OS): defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact (regardless of whether or not this contact is on a subsequent protocol). Survival (PFS and OS) were analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.

Outcome measures

Outcome measures
Measure	Avastin and Docetaxel n=41 Participants Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Overall Survival (OS)	12.4 months Interval 10.0 to 21.9

Adverse Events

Avastin and Docetaxel

Serious events: 27 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Avastin and Docetaxel n=41 participants at risk Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Gastrointestinal disorders Fistula, GI - Colon/cecum/appendix	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Obstruction, GI - Small bowel, NOS	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Perforation, GI - Small bowell, NOS	4.9% 2/41 • 4 years Participants who received 1 to 278 treatment cycles.
Infections and infestations Febrile neutropenia	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	4.9% 2/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Pain - Back	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	4.9% 2/41 • 4 years Participants who received 1 to 278 treatment cycles.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	14.6% 6/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Fatigue (asthemia, lethargy, malaise)	12.2% 5/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Anorexia	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Blood and lymphatic system disorders Lymphopenia	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Gastrointestinal - Other	4.9% 2/41 • 4 years Participants who received 1 to 278 treatment cycles.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	4.9% 2/41 • 4 years Participants who received 1 to 278 treatment cycles.
Blood and lymphatic system disorders leukocytes (total WBC)	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation - Chemoradiation	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Taste alteration (dysgeusia)	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Pain - Stomach	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Endocrine disorders Hot flashes/flushes	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Pain - Kidney	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Musculoskeletal and connective tissue disorders Neuropathy: sensory	4.9% 2/41 • 4 years Participants who received 1 to 278 treatment cycles.
Blood and lymphatic system disorders Platelets	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Ileus, GI (functional obsturction of bowel, i.e., neuroconstipation)	2.4% 1/41 • 4 years Participants who received 1 to 278 treatment cycles.

Other adverse events

Other adverse events
Measure	Avastin and Docetaxel n=41 participants at risk Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Gastrointestinal disorders Diarrhea	46.3% 19/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Taste alteration (dysgeusia)	39.0% 16/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Anorexia	39.0% 16/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Nausea	36.6% 15/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	29.3% 12/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Gastrointestinal - other	19.5% 8/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Constipation	19.5% 8/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Heartburn/dyspepsia	19.5% 8/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Vomiting	19.5% 8/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Distention/bloating, abdominal	12.2% 5/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) - Oral cavity	12.2% 5/41 • 4 years Participants who received 1 to 278 treatment cycles.
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Fatigue	43.9% 18/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Constitutional Symptoms - Other	24.4% 10/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Insomnia	12.2% 5/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Rigors/chills	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Weight gain	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Weight loss	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Fever (in the absence of neutropenia)	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	61.0% 25/41 • 4 years Participants who received 1 to 278 treatment cycles.
Skin and subcutaneous tissue disorders Nail changes	43.9% 18/41 • 4 years Participants who received 1 to 278 treatment cycles.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
Skin and subcutaneous tissue disorders Rash/desquamation	14.6% 6/41 • 4 years Participants who received 1 to 278 treatment cycles.
Skin and subcutaneous tissue disorders Bruising (in absence of Grade 3 or 4 thrombocytopenia)	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
Skin and subcutaneous tissue disorders Dry skin	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Pain - abdomen, NOS	31.7% 13/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Pain - Head/headache	17.1% 7/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Pain - Other	17.1% 7/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Pain - Oral cavity	12.2% 5/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Pain - Back	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Pain - Chest/thorax, NOS	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	29.3% 12/41 • 4 years Participants who received 1 to 278 treatment cycles.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	19.5% 8/41 • 4 years Participants who received 1 to 278 treatment cycles.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Nervous system disorders Neuropathy: sensory	41.5% 17/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Dizziness	12.2% 5/41 • 4 years Participants who received 1 to 278 treatment cycles.
Nervous system disorders Neuropathy: motor	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Eye disorders Watery eye (epiphora, tearing)	58.5% 24/41 • 4 years Participants who received 1 to 278 treatment cycles.
Eye disorders Vision-blurred vision	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
Eye disorders Dry eye syndrome	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Eye disorders Ocular/Visual - Other	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	29.3% 12/41 • 4 years Participants who received 1 to 278 treatment cycles.
Blood and lymphatic system disorders Leukocytes (total WBC)	19.5% 8/41 • 4 years Participants who received 1 to 278 treatment cycles.
Blood and lymphatic system disorders Hemoglobin	22.0% 9/41 • 4 years Participants who received 1 to 278 treatment cycles.
Blood and lymphatic system disorders Lymphopenia	12.2% 5/41 • 4 years Participants who received 1 to 278 treatment cycles.
Blood and lymphatic system disorders Platelets	14.6% 6/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Hemorrhage, pulmonary/upper respiratory - Nose	39.0% 16/41 • 4 years Participants who received 1 to 278 treatment cycles.
General disorders Hemorrhage/Bleeding - Other	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	14.6% 6/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders Metabolic/Laboratory - Other	12.2% 5/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	12.2% 5/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders Alkaline phosphatase	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Infections and infestations Febrile neutropenia (fever of unknown origin)	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Infections and infestations Infection with unknown ANC - Urinary tract, NOS	7.3% 3/41 • 4 years Participants who received 1 to 278 treatment cycles.
Immune system disorders Allergic rhinitis	17.1% 7/41 • 4 years Participants who received 1 to 278 treatment cycles.
Endocrine disorders Hot flashes/flushes	22.0% 9/41 • 4 years Participants who received 1 to 278 treatment cycles.
Cardiac disorders Hypertension	14.6% 6/41 • 4 years Participants who received 1 to 278 treatment cycles.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
Blood and lymphatic system disorders Edema: limb	9.8% 4/41 • 4 years Participants who received 1 to 278 treatment cycles.
Respiratory, thoracic and mediastinal disorders Cough	31.7% 13/41 • 4 years Participants who received 1 to 278 treatment cycles.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other	22.0% 9/41 • 4 years Participants who received 1 to 278 treatment cycles.

Additional Information

Robert Wenham, Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-8478

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place