Fallopian Tube CancerPhase 2NCT00838656
Two Different Schedules of Carboplatin, Paclitaxel, Gemcitabine, and Surgery in Treating Patients With Newly Diagnosed Stage IIIC or Stage IV Primary Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
A Phase 2 study testing carboplatin, gemcitabine hydrochloride and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Warwick Medical School at 4 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- carboplatin, gemcitabine hydrochloride and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Oct 2007to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Clinically, radiologically, and histologically confirmed diagnosis of 1 of the following:
- Primary epithelial ovarian cancer
- Primary peritoneal carcinoma
- Ovarian carcinosarcoma
- Fallopian tube carcinoma
- Newly diagnosed, stage IIIC/IV disease with or without ascites
- None of the following histologies allowed:
- Mucinous
- Classic clear cell
- Micropapillary or microacinar borderline tumors with or without invasive implants
- Unsuitable for primary debulking surgery, as defined by the following:
- Laparoscopic or other minor surgical-staging procedures
- Supplementary clinical and radiological assessments
- Presenting with factors affecting suitability for successful complete resection and necessarily prompting laparoscopic assessment, including any of the following:
- CT scan or MRI evidence of peritoneal carcinomatosis, extensive mesenteric infiltration, diaphragmatic involvement, extensive retroperitoneal involvement, and cytologically verified malignant pleural effusion and/or ascites
- Clinical evidence of ascites with radiological evidence of multisite disease
- Clinical evidence of pelvic infiltration and radiological evidence of multisite disease
- FIGO stage IV disease, including cervical/supraclavicular lymphadenopathy, intrahepatic parenchymal metastases, or cytologically confirmed malignant pleural effusion
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Life expectancy ≥ 3 months
- WBC > 3.0/mm³
- Platelet count ≥ 100,000/mm³
- ANC ≥ 1,500/mm³
- AST and ALT < 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 2.5 times ULN
- Bilirubin < 1.5 times ULN
- Estimated glomerular filtration rate ≥ 30 mL/min
- No diabetics, hypertensive smokers, or other patients with pre-existing occult neuropathic deficits
- No poorly controlled, potentially serious medical conditions, including any of the following:
- Cerebrovascular events within the past 12 months
- Severe chronic respiratory conditions requiring prior hospitalization
- Active infections
- Poorly controlled seizures
- Morbid psychiatric conditions likely to render treatment compliance with the protocol difficult
- No other malignancy treated with chemotherapy or radiotherapy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- Prior malignancies disease-free for > 5 years not treated with chemotherapy allowed
- No other reasons likely to cause inability to comply with treatment schedule and follow-up
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH
Good Hope Hospital
Birmingham, England, B75 7RR
Birmingham Heartlands Hospital
Birmingham, England, B9 5SS
New Cross Hospital
Wolverhampton, England, WV10 0QP
About this study
Official title: A Randomised Feasibility Study of Extended Chemotherapy With Neoadjuvant Carboplatin, Then Surgery Followed by Adjuvant Paclitaxel and Gemcitabine Verses Neoadjuvant Gemcitabine and Carboplatin, Then Surgery, Followed by Adjuvant Paclitaxel
RATIONALE: Drugs used in chemotherapy, such as carboplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which treatment regimen may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving one of two chemotherapy regimens containing carboplatin, gemcitabine, and paclitaxel works in treating patients undergoing surgery for newly diagnosed primary stage IIIC or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Read the detailed description
OBJECTIVES:
- To examine and compare the feasibility of two sequential neoadjuvant regimens in patients with newly diagnosed, stage IIIC-IV ovarian or peritoneal carcinoma.
- To confirm the feasibility of extended sequential regimens offering 6+6 courses of chemotherapy in patients presenting with inoperable disease.
- To establish the feasibility of biweekly paclitaxel with vs without gemcitabine hydrochloride in the adjuvant phase, after carboplatin neoadjuvant induction.
OUTLINE: This is a multicenter study. Patients are stratified according to serum albumin (< 30 g/dL vs 30-35 g/dL vs > 35 g/dL), FIGO stage (stage IIIC vs stage IV), and histological grade (well-differentiated [grade 1] vs moderately well-differentiated [grade 2] vs poorly differentiated [grade 3]). Patients are randomized to 1 of 2 treatment arms.
- Neoadjuvant therapy:
- Arm I: Patients receive carboplatin IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
In both arms, patients with disease progression are switched to adjuvant paclitaxel-based chemotherapy. Patients with responding disease after switching regimens may undergo debulking surgery at the investigator's discretion.
- Surgery: After completion of 6 courses of chemotherapy, all patients are evaluated for surgery. Patients with questionable operability based on clinical or radiological criteria are re-assessed laparoscopically. Patients judged to have disease that is amenable to optimal debulking at laparotomy are recommended for debulking surgery. Patients judged to have disease that is not amenable to optimal debulking are reconsidered for surgery after they receive an additional 6 courses of chemotherapy. Patients with disease progression after completion of 12 courses of chemotherapy undergo laparotomy only if there is a clinically pressing need to palliate their condition and if surgery offers some prospect of achieving this result (e.g., palliation for bowel obstruction).
- Adjuvant therapy:
- Arm I: Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV over 3 hours and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, after completion of course 6 of neoadjuvant therapy, before course 7, and at the end of study treatment.
After completion of study therapy, patients are followed periodically for up to 10 years.
- Being tested
- carboplatin, gemcitabine hydrochloride, paclitaxel
- Keywords
- ovarian carcinosarcoma, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Given IV in one of two schedules
Given IV in one of two schedules
paclitaxelDrug
Given IV in one of two schedules
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive carboplatin IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo treatment with paclitaxel and may also receive 6 more courses of neoadjuvant chemotherapy. Patients may then undergo surgery. After surgery, patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: carboplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel |
| Arm II | Experimental | Patients receive carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo treatment with paclitaxel and may also receive 6 more courses of neoadjuvant chemotherapy. Patients may then undergo surgery. After surgery, patients receive paclitaxel IV over 3 hours and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: carboplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients completing 12 courses of chemotherapy
Secondary outcomes (7)
Toxicity
Quality of life as assessed by FACT-G, FACT-0, and FACT-T periodically
Objective response rate to the neoadjuvant phase of chemotherapy (i.e., first 6 courses) as assessed by CT scan, by laparoscopy, clinically, and by CA-125 level
Objective response rate following all 12 courses of treatment assessed clinically, by CT scan, and by CA-125 level
Progression-free survival, particularly at 34 weeks
Overall survival, particularly at 34 weeks
Rates of optimal and suboptimal interval debulking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startOct 2007
- Primary completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Warwick Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Christopher Poole, MD, Principal investigator, University Hospital Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838656
- Sponsor's protocol ID
- CDR0000632859
- Other IDs
- WMS-NEOESCAPE-AK/RH/22498/1, ISRCTN24742183, EUDRACT-2005-001875-37, EU-20904, MREC-07/Q2803/73, RG_05-003
- Status last verified
- Jun 2011
- First submitted
- 5 Feb 2009
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Feasibility Study of Extended Chemotherapy With Neoadjuvant Carboplatin, Then Surgery Followed by Adjuvant Paclitaxel and Gemcitabine Verses Neoadjuvant Gemcitabine and Carboplatin, Then Surgery, Followed by Adjuvant Paclitaxel
- ClinicalTrials.gov ID
- NCT00838656
- Acronym / sponsor ID
- CDR0000632859
- Keywords
- ovarian carcinosarcoma, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Warwick Medical SchoolUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jun 2009 (estimated)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as carboplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which treatment regimen may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving one of two chemotherapy regimens containing carboplatin, gemcitabine, and paclitaxel works in treating patients undergoing surgery for newly diagnosed primary stage IIIC or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Detailed description
OBJECTIVES:
- To examine and compare the feasibility of two sequential neoadjuvant regimens in patients with newly diagnosed, stage IIIC-IV ovarian or peritoneal carcinoma.
- To confirm the feasibility of extended sequential regimens offering 6+6 courses of chemotherapy in patients presenting with inoperable disease.
- To establish the feasibility of biweekly paclitaxel with vs without gemcitabine hydrochloride in the adjuvant phase, after carboplatin neoadjuvant induction.
OUTLINE: This is a multicenter study. Patients are stratified according to serum albumin (< 30 g/dL vs 30-35 g/dL vs > 35 g/dL), FIGO stage (stage IIIC vs stage IV), and histological grade (well-differentiated [grade 1] vs moderately well-differentiated [grade 2] vs poorly differentiated [grade 3]). Patients are randomized to 1 of 2 treatment arms.
- Neoadjuvant therapy:
- Arm I: Patients receive carboplatin IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
In both arms, patients with disease progression are switched to adjuvant paclitaxel-based chemotherapy. Patients with responding disease after switching regimens may undergo debulking surgery at the investigator's discretion.
- Surgery: After completion of 6 courses of chemotherapy, all patients are evaluated for surgery. Patients with questionable operability based on clinical or radiological criteria are re-assessed laparoscopically. Patients judged to have disease that is amenable to optimal debulking at laparotomy are recommended for debulking surgery. Patients judged to have disease that is not amenable to optimal debulking are reconsidered for surgery after they receive an additional 6 courses of chemotherapy. Patients with disease progression after completion of 12 courses of chemotherapy undergo laparotomy only if there is a clinically pressing need to palliate their condition and if surgery offers some prospect of achieving this result (e.g., palliation for bowel obstruction).
- Adjuvant therapy:
- Arm I: Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV over 3 hours and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, after completion of course 6 of neoadjuvant therapy, before course 7, and at the end of study treatment.
After completion of study therapy, patients are followed periodically for up to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: carboplatin, Drug: gemcitabine hydrochloride, Drug: paclitaxelPatients receive carboplatin IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo treatment with paclitaxel and may also receive 6 more courses of neoadjuvant chemotherapy. Patients may then undergo surgery. After surgery, patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| Arm II | Experimental | Drug: carboplatin, Drug: gemcitabine hydrochloride, Drug: paclitaxelPatients receive carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo treatment with paclitaxel and may also receive 6 more courses of neoadjuvant chemotherapy. Patients may then undergo surgery. After surgery, patients receive paclitaxel IV over 3 hours and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatinGiven IV in one of two schedules | Drug | Arm I, Arm II |
| gemcitabine hydrochlorideGiven IV in one of two schedules | Drug | Arm I, Arm II |
| paclitaxelGiven IV in one of two schedules | Drug | Arm I, Arm II |
Primary outcome
Percentage of patients completing 12 courses of chemotherapy
7 secondary outcomes
Toxicity
Quality of life as assessed by FACT-G, FACT-0, and FACT-T periodically
Objective response rate to the neoadjuvant phase of chemotherapy (i.e., first 6 courses) as assessed by CT scan, by laparoscopy, clinically, and by CA-125 level
Objective response rate following all 12 courses of treatment assessed clinically, by CT scan, and by CA-125 level
Progression-free survival, particularly at 34 weeks
Overall survival, particularly at 34 weeks
Rates of optimal and suboptimal interval debulking
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Poole, MD principal investigator
University Hospital Birmingham
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, gemcitabine hydrochloride and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Warwick Medical School at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients completing 12 courses of chemotherapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.