Head and Neck CancerPhase 1NCT00006036
Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing cisplatin and lurtotecan liposome in people with Head and Neck Cancer and Lung Cancer, run by NCIC Clinical Trials Group at 3 sites in Canada.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer, Ovarian Cancer
- What is being tested?
- cisplatin and lurtotecan liposome
- How many people
- 14 participants
- Where
- 3 sitesCanada
- Study dates
- 22 Mar 2000to 21 Dec 2009
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced and/or metastatic solid tumor refractory to standard curative therapy or for which no curative therapy exists Clinically or radiographically documented disease No tumor marker elevation as only evidence of disease No untreated brain or meningeal metastases Previously treated and stable CNS metastases allowed (i.e., no evidence of increasing disease by CT scan for at least 4 weeks) Recommended phase II dose portion of study: Previously untreated advanced and/or metastatic disease for which a cisplatin-based regimen is indicated (e.g., non-small cell lung cancer, small cell lung cancer, ovarian, or head and neck cancer) At least one measurable lesion at least 20 mm by physical exam or x-ray or at least 10 mm by spiral CT scan
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN (5 times ULN if documented liver metastases) Renal: Creatinine no greater than ULN OR Creatinine clearance at least 60 mL/min Other: No greater than grade 1 neuropathy or ototoxicity No other prior or concurrent malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or cervical cancer (for recommended phase II dose) No active or uncontrolled infections No other serious illnesses or medical conditions that would preclude study No known hypersensitivity to systemic liposomal formulation or any drug chemically related to study drug Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy Recovered from prior immunotherapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen (adjuvant and/or metastatic) except for nonmyelosuppressive agents (e.g., signal transduction inhibitors or immunotherapy) At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin and 4 weeks for carboplatin) and recovered At least 1 year since prior high-dose chemotherapy with marrow or stem cell support No prior total cisplatin dose of more than 300 mg/m2 No prior chemotherapy (for recommended phase II dose) Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of bone marrow reserve, except for low-dose nonmyelosuppression Surgery: Not specified Other: At least 4 weeks since other prior experimental drugs or anticancer therapy and recovered No other concurrent investigational or anticancer therapy
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Toronto General Hospital
Toronto, Ontario, M5G 2C4
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase I Study of NX 211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2, and 3 Every 3 Weeks in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of liposomal lurtotecan plus cisplatin in treating patients who have advanced or metastatic solid tumors.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of lurtotecan liposome and cisplatin in patients with advanced solid tumors. II. Determine the toxicity profile, dose-limiting toxic effects, and the pharmacokinetics of this treatment regimen in this patient population. III. Determine any correlation between toxicity profile and pharmacokinetics of this treatment regimen in these patients. IV. Determine the objective tumor response to this treatment regimen in patients with measurable disease (previously untreated solid tumors) entered at the recommended phase II dose.
OUTLINE: This is an open-label, multicenter, dose-escalation study of lurtotecan liposome. Patients receive cisplatin IV over 1 hour followed by lurtotecan liposome IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Once the total dose of cisplatin is reached, patients receive lurtotecan liposome alone. Patients achieving complete response (CR) continue therapy for 2 courses after documentation of confirmed CR. Patients achieving partial response (PR) continue therapy until progression or for 2 courses after documentation of stable PR. Patients with stable disease continue therapy for a maximum of 6 courses. Cohorts of 3-6 patients receive escalating doses of lurtotecan liposome until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 10 patients with previously untreated solid tumors are treated at the recommended phase II dose (1 dose below the MTD). Patients are followed at 4 weeks and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15 months.
- Conditions
- Head and Neck Cancer, Lung Cancer, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- cisplatin, lurtotecan liposome
- Keywords
- recurrent non-small cell lung cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage IV nasopharyngeal cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, unspecified adult solid tumor, protocol specific, untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, ovarian stromal cancer, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, stage III squamous cell carcinoma of the lip and oral cavity, stage III basal cell carcinoma of the lip, stage III verrucous carcinoma of the oral cavity
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Ovarian Epithelial, Small Cell Lung Carcinoma, Nasopharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
lurtotecan liposomeDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2004 (estimated)
- Study start22 Mar 2000
- Primary completion26 Sep 2002
- Study completion21 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hal W. Hirte, MD, FRCP(C), Study chair, Margaret and Charles Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006036
- Sponsor's protocol ID
- I133
- Other IDs
- CAN-NCIC-IND133, NEXSTAR-110-05, CDR0000068051
- Status last verified
- Apr 2020
- First submitted
- 5 Jul 2000
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MacKenzie MJ, Hirte HW, Siu LL, Gelmon K, Ptaszynski M, Fisher B, Eisenhauer E. A phase I study of OSI-211 and cisplatin as intravenous infusions given on days 1, 2 and 3 every 3 weeks in patients with solid cancers. Ann Oncol. 2004 Apr;15(4):665-70. doi: 10.1093/annonc/mdh133.
PubMed 15033677
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of NX 211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2, and 3 Every 3 Weeks in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00006036
- Acronym / sponsor ID
- I133
- Conditions
- Head and Neck Cancer, Lung Cancer, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- recurrent non-small cell lung cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage IV nasopharyngeal cancer, stage IIIA non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 22 Mar 2000 (actual)
- Primary completion
- 26 Sep 2002 (actual)
- Study completion
- 21 Dec 2009 (actual)
- First posted
- 25 Mar 2004 (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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of liposomal lurtotecan plus cisplatin in treating patients who have advanced or metastatic solid tumors.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of lurtotecan liposome and cisplatin in patients with advanced solid tumors. II. Determine the toxicity profile, dose-limiting toxic effects, and the pharmacokinetics of this treatment regimen in this patient population. III. Determine any correlation between toxicity profile and pharmacokinetics of this treatment regimen in these patients. IV. Determine the objective tumor response to this treatment regimen in patients with measurable disease (previously untreated solid tumors) entered at the recommended phase II dose.
OUTLINE: This is an open-label, multicenter, dose-escalation study of lurtotecan liposome. Patients receive cisplatin IV over 1 hour followed by lurtotecan liposome IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Once the total dose of cisplatin is reached, patients receive lurtotecan liposome alone. Patients achieving complete response (CR) continue therapy for 2 courses after documentation of confirmed CR. Patients achieving partial response (PR) continue therapy until progression or for 2 courses after documentation of stable PR. Patients with stable disease continue therapy for a maximum of 6 courses. Cohorts of 3-6 patients receive escalating doses of lurtotecan liposome until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 10 patients with previously untreated solid tumors are treated at the recommended phase II dose (1 dose below the MTD). Patients are followed at 4 weeks and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- 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 |
|---|---|---|
| cisplatin | Drug | – |
| lurtotecan liposome | 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 6 Apr 2020.
- Results publication: PubMed 15033677MacKenzie MJ, Hirte HW, Siu LL, Gelmon K, Ptaszynski M, Fisher B, Eisenhauer E. A phase I study of OSI-211 and cisplatin as intravenous infusions given on days 1, 2 and 3 every 3 weeks in patients with solid cancers. Ann Oncol. 2004 Apr;15(4):665-70. doi: 10.1093/annonc/mdh133.
- Individual participant dataSharing planned: No
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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.
Hal W. Hirte, MD, FRCP(C) study chair
Margaret and Charles Juravinski Cancer Centre
3 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 cisplatin and lurtotecan liposome in people with Head and Neck Cancer and Lung Cancer, run by NCIC Clinical Trials Group at 3 sites in Canada.
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: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006036, which also lists 1 linked publication.
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 6 Apr 2020.