Ovarian NeoplasmPhase 2NCT00001426
A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer
A Phase 2 study testing Cyclophosphamide, Paclitaxel and Cisplatin in people with Ovarian Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Neoplasm
- What is being tested?
- Cyclophosphamide, Paclitaxel and Cisplatin
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 1995to 7 Nov 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients must have biopsy proven, newly diagnosed epithelial ovarian cancer, primary epithelial fallopian tube cancer, or peritoneal surface carcinoma. Histopathologic diagnosis must be confirmed in the pathology department of the treating institution prior to initiation of therapy. Diagnosis will be confirmed in the Laboratory of Pathology, National Cancer Institute. This confirmation is not necessary prior to entering the patient onto protocol.
- Patients must have FIGO stage III or IV disease and will undergo attempted surgical debulking prior to the initiation of chemotherapy.
- Patients must be able to begin therapy within 6 weeks of staging laparotomy and should have an indwelling venous access device placed. A double lumen catheter is preferred.
- Performance status of less than or equal to ECOG 2.
- Patients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol.
- All patients must be registered by calling the Orkand Corporation at 301-402-1732 between the hours of 8:30 AM and 5:00 PM EST; Eligibility criteria will be queried.
Who cannot join
- Evidence CNS involvement (patients with normal clinical exam will not require a head CT scan or MRI).
- History of myocardial infarction or unstable dysrhythmia within 1 month of study entry.
- Creatinine clearance of less than 60 cc/min, ANC less than 1000/cm3, platelet count less than 1000,000/cm3.
- History of active GI bleeding within the last 30 days.
- Prior therapy other than surgery for this malignancy.
- Abnormal PT, PTT, and bilirubin. SGOT greater than or equal to 3 times the upper limit of normal.
Show all 9Show fewer
- Previous history of invasive malignancy.
- Patients with ureteral obstruction must have this corrected prior to starting therapy.
- Patients with germ cell, mixed Muellerian and borderline histologies are specifically excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
Read the detailed description
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
- Conditions
- Ovarian Neoplasm
- Being tested
- Cyclophosphamide, Paclitaxel, Cisplatin, G-CSF
- Keywords
- Ovarian Cancer, Initial Therapy, Paclitaxel, Cisplatin, Cyclophosphamide
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
PaclitaxelDrug
CisplatinDrug
G-CSFDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start3 Feb 1995
- Primary completion15 Oct 2007
- Study completion7 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Elise C Kohn, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001426
- Sponsor's protocol ID
- 950055
- Other IDs
- 95-C-0055
- Status last verified
- 7 Nov 2013
- First submitted
- 3 Nov 1999
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Kohn EC, Sarosy GA, Davis P, Christian M, Link CE, Ognibene FP, Sindelar WF, Jacob J, Steinberg SM, Premkumar A, Reed E. A phase I/II study of dose-intense paclitaxel with cisplatin and cyclophosphamide as initial therapy of poor-prognosis advanced-stage epithelial ovarian cancer. Gynecol Oncol. 1996 Aug;62(2):181-91. doi: 10.1006/gyno.1996.0213.
PubMed 8751547Reed E, Kohn EC, Sarosy G, Dabholkar M, Davis P, Jacob J, Maher M. Paclitaxel, cisplatin, and cyclophosphamide in human ovarian cancer: molecular rationale and early clinical results. Semin Oncol. 1995 Jun;22(3 Suppl 6):90-6.
PubMed 7541159Link CJ Jr, Sarosy GA, Kohn EC, Christian MC, Davis P, Adamo DO, Reed E. Cutaneous manifestations of Taxol therapy. Invest New Drugs. 1995;13(3):261-3. doi: 10.1007/BF00873811.
PubMed 8729957
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00001426
- Acronym / sponsor ID
- 950055
- Conditions
- Ovarian Neoplasm
- Keywords
- Ovarian Cancer, Initial Therapy, Paclitaxel, Cisplatin, Cyclophosphamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 3 Feb 1995
- Primary completion
- 15 Oct 2007 (actual)
- Study completion
- 7 Nov 2013 (actual)
- First posted
- 4 Nov 1999 (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.
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
Detailed description
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- All patients must have biopsy proven, newly diagnosed epithelial ovarian cancer, primary epithelial fallopian tube cancer, or peritoneal surface carcinoma. Histopathologic diagnosis must be confirmed in the pathology department of the treating institution prior to initiation of therapy. Diagnosis will be confirmed in the Laboratory of Pathology, National Cancer Institute. This confirmation is not necessary prior to entering the patient onto protocol.
- Patients must have FIGO stage III or IV disease and will undergo attempted surgical debulking prior to the initiation of chemotherapy.
- Patients must be able to begin therapy within 6 weeks of staging laparotomy and should have an indwelling venous access device placed. A double lumen catheter is preferred.
- Performance status of less than or equal to ECOG 2.
- Patients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol.
Key exclusion criteria (9 listed)
- Evidence CNS involvement (patients with normal clinical exam will not require a head CT scan or MRI).
- History of myocardial infarction or unstable dysrhythmia within 1 month of study entry.
- Creatinine clearance of less than 60 cc/min, ANC less than 1000/cm3, platelet count less than 1000,000/cm3.
- History of active GI bleeding within the last 30 days.
- Prior therapy other than surgery for this malignancy.
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 |
|---|---|---|
| Cyclophosphamide | Drug | – |
| Paclitaxel | Drug | – |
| Cisplatin | Drug | – |
| G-CSF | Drug | – |
Primary outcome
Not reported in the source record.
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 5 Apr 2018.
- Background: PubMed 8751547Kohn EC, Sarosy GA, Davis P, Christian M, Link CE, Ognibene FP, Sindelar WF, Jacob J, Steinberg SM, Premkumar A, Reed E. A phase I/II study of dose-intense paclitaxel with cisplatin and cyclophosphamide as initial therapy of poor-prognosis advanced-stage epithelial ovarian cancer. Gynecol Oncol. 1996 Aug;62(2):181-91. doi: 10.1006/gyno.1996.0213.
- Background: PubMed 7541159Reed E, Kohn EC, Sarosy G, Dabholkar M, Davis P, Jacob J, Maher M. Paclitaxel, cisplatin, and cyclophosphamide in human ovarian cancer: molecular rationale and early clinical results. Semin Oncol. 1995 Jun;22(3 Suppl 6):90-6.
- Background: PubMed 8729957Link CJ Jr, Sarosy GA, Kohn EC, Christian MC, Davis P, Adamo DO, Reed E. Cutaneous manifestations of Taxol therapy. Invest New Drugs. 1995;13(3):261-3. doi: 10.1007/BF00873811.
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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.
Elise C Kohn, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Paclitaxel and Cisplatin in people with Ovarian Neoplasm, run by National Cancer Institute (NCI) at 1 site 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 6 inclusion and 9 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001426, which also lists 3 linked publications.
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 5 Apr 2018.