Chemotherapeutic Agent ToxicityPhase 1NCT00814086
Cisplatin and Paclitaxel in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
A Phase 1 study testing Paclitaxel and Cisplatin in people with Chemotherapeutic Agent Toxicity and Endometrial Adenocarcinoma, run by Gynecologic Oncology Group at 7 sites in United States.
Trial summary
This phase I trial is studying the side effects and best dose of cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Chemotherapeutic Agent Toxicity, Endometrial Adenocarcinoma, Fallopian Tube Carcinoma
- What is being tested?
- Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2009to Jul 2011
- Phase
- Phase 1
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- Stage IIB, IIC, III, or IV disease
- Optimal or suboptimal residual disease after debulking surgery within the past 12 weeks
- Appropriate tissue for histologic evaluation available
- The following histologic epithelial cell types are eligible:
- Serous adenocarcinoma
Show all 50Show fewer
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell carcinoma
- Malignant Brenner tumor
- Adenocarcinoma not otherwise specified
- Carcinosarcoma
- No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
- No synchronous primary endometrial cancer or a history of primary endometrial cancer unless all of the following conditions are met:
- Stage ≤ IB disease
- No more than superficial myometrial invasion, without vascular or lymphatic invasion
- No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion
- GOG performance status 0-2
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- SGOT ≤ 2.5 times ULN
- Audiograms required after study chemotherapy courses 3 and 6 for patients with hearing loss, or who are experiencing tinnitus during study therapy
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception
- None of the following:
- Septicemia
- Severe infection requiring parenteral antibiotics
- Malnutrition requiring parenteral hyperalimentation
- Acute hepatitis
- Any other major medical conditions expected to interfere with completion of protocol therapy
- No active bleeding
- No circumstances that would prohibit completion of study therapy or required follow-up
- No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E)
- No other invasive malignancies, except for nonmelanoma skin cancer or other specific malignancies within the past 5 years, or whose previous cancer treatment contraindicates this protocol therapy
- No unstable angina or myocardial infarction within the past 6 months
- Abnormal cardiac conduction (e.g., bundle branch block or heart block) that has been stable for the past 6 months allowed
- No prior targeted therapy for the management of ovarian epithelial or primary peritoneal cavity cancer including, but not limited to, the following:
- Vaccines
- Antibodies
- Tyrosine kinase inhibitors
- No prior chemotherapy
- No prior radiotherapy
- No prior hormonal therapy for the management of epithelial ovarian or primary peritoneal cavity cancer
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Riverside Methodist Hospital
Columbus, Ohio, 43214
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Women and Infants Hospital
Providence, Rhode Island, 02905
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146
About this study
Official title: A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day 1 Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
This phase I trial is studying the side effects and best dose of cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as cisplatin 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 more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of intraperitoneal (IP) cisplatin and intravenous (IV) paclitaxel followed by IP paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.
SECONDARY OBJECTIVES:
- Assess the toxicity of this regimen in these patients. II. Determine the types of surgical and catheter complications that may occur after surgery or during the course of treatment in these patients.
III. Estimate the response rate in patients with measurable disease treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 1 year.
- Conditions
- Chemotherapeutic Agent Toxicity, Endometrial Adenocarcinoma, Fallopian Tube Carcinoma, Gastrointestinal Complication, Malignant Ovarian Mixed Epithelial Tumor, Neurotoxicity Syndrome
- Being tested
- Paclitaxel, Cisplatin
- Medical subject headings
- Fallopian Tube Neoplasms, Neurotoxicity Syndromes, Brenner Tumor, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Anzatax, TAX
Given IV or intraperitoneally
CisplatinDrug
Given intraperitoneally
| Study group | Role | What they receive |
|---|---|---|
| Treatment (paclitaxel, cisplatin) | Experimental | Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks
Measured: 12 weeks
Secondary outcomes (3)
Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Measured: Up to 1 year
Adverse events related to the catheter or the surgical placement of the catheter
Measured: Up to 1 year
Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapeutic Agent ToxicityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Don Dizon, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814086
- Sponsor's protocol ID
- GOG-9921
- Other IDs
- NCI-2009-00624, GOG-9921, CDR0000629746, GOG-9921, GOG-9921, U10CA027469
- Status last verified
- Dec 2014
- First submitted
- 20 Dec 2008
- Last updated
- 31 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day 1 Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT00814086
- Acronym / sponsor ID
- GOG-9921
- Conditions
- Chemotherapeutic Agent Toxicity, Endometrial Adenocarcinoma, Fallopian Tube Carcinoma, Gastrointestinal Complication, Malignant Ovarian Mixed Epithelial Tumor, Neurotoxicity Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- First posted
- 23 Dec 2008 (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.
This phase I trial is studying the side effects and best dose of cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as cisplatin 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 more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of intraperitoneal (IP) cisplatin and intravenous (IV) paclitaxel followed by IP paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.
SECONDARY OBJECTIVES:
- Assess the toxicity of this regimen in these patients. II. Determine the types of surgical and catheter complications that may occur after surgery or during the course of treatment in these patients.
III. Estimate the response rate in patients with measurable disease treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (paclitaxel, cisplatin) | Experimental | Drug: Paclitaxel, Drug: CisplatinPatients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (50 listed)
- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- The following histologic epithelial cell types are eligible:
- No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
- No synchronous primary endometrial cancer or a history of primary endometrial cancer unless all of the following conditions are met:
- GOG performance status 0-2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PaclitaxelAlso: Anzatax, TAXGiven IV or intraperitoneally | Drug | Treatment (paclitaxel, cisplatin) |
| CisplatinGiven intraperitoneally | Drug | Treatment (paclitaxel, cisplatin) |
Primary outcome
Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks
Time frame: 12 weeks
3 secondary outcomes
Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Time frame: Up to 1 year
Adverse events related to the catheter or the surgical placement of the catheter
Time frame: Up to 1 year
Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
Related trials for Chemotherapeutic Agent Toxicity
Recruiting
Daily Hand-Held Vibration Therapy
Neuropathy, Cancer
Active, not recruitingPhase 2
Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab
Urologic Neoplasms, Urogenital Neoplasms
RecruitingPhase 4
The STOP-MED CTRCD Trial
Heart Failure, Cardiotoxicity
Active, not recruitingPhase 2
Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer
Breast Neoplasms, HER2/Neu Positive
Recruiting
Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients
Head and Neck Squamous Cell Carcinoma, Locally Advanced Rectal Cancer
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.
Don Dizon principal investigator
Gynecologic Oncology Group
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paclitaxel and Cisplatin in people with Chemotherapeutic Agent Toxicity and Endometrial Adenocarcinoma, run by Gynecologic Oncology Group at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 50 inclusion and 0 exclusion criteria. 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: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks (time frame: 12 weeks). 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 31 Dec 2014.