Lung CancerPhase 1/2NCT00043823
Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
A Phase 1/2 study testing Avastin and Tarceva in people with Lung Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
Primary Objectives: 1. (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC). 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Avastin and Tarceva
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2002to 15 May 2006
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has histologically proven stage IIIB with pleural effusion, stage IV or recurrent non-squamous NSCLC.
- Patient has a Karnofsky performance status >=70%.
- Patient has adequate bone marrow function: WBC >= 3,000 cells/mm3, ANC >= 1,500 cells/mm3, platelet count >= 100,000 cells/mm3, Hgb >= 9.0 g/dL.
- Patient has adequate liver function: total bilirubin level <= 2.0 mg/dL, albumin >= 2.5 g/dL.
- Transaminases (aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT)) and alkaline phosphatase may be up to 2.5 x ULN.
- Patient has adequate renal function: a serum creatinine < 2 mg/dl
- Patient has signed a written informed consent.
- Patient has received at least one prior chemotherapeutic regimen for recurrent or metastatic disease.
Who cannot join
- Patient has not received prior chemotherapeutic regimens for advanced disease.
- Patient has received prior biologic therapy targeting epidermal growth factor receptor (EGFR) and/or Vascular endothelial growth factor (VEGF).
- Patient has received radiation therapy within the past 3 weeks.
- Patient has signs or symptoms of acute infection requiring systemic therapy.
- Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
- Patient requires total parenteral nutrition with lipids.
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- Patient has a history of uncontrolled heart disease and/or uncontrolled hypertension (> 150/100 mmHg).
- Because of the possible teratogenic effect, pregnant women and women who are currently breast-feeding may not participate in this study. - All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study.
- Serious infection or other intercurrent illness requiring immediate therapy.
- Clinical/imaging evidence of Central Nervous System (CNS) malignancy or with recently treated CNS malignancy, as well as those experiencing recent cerebrovascular accident (CVA), or other CNS bleeding.
- Pediatric patients in whom open growth plates would be expected.
- Urine protein qualitative value of > 30 in urinalysis or > +1 in proteinuria testing by dipstick.
- Patient has a clinical history of coagulopathy or thrombosis.
- Patient is currently receiving or intending to receive anti-coagulants.
- Patient has had a recent myocardial infarction (still inside the healing period). Note: a six-month window is optimal.
- Patient is recovering from recent major surgery (e.g., less than 2 weeks since surgery) or is anticipating major surgery.
- Patient has a clinical history of hemoptysis or hematemesis.
- Patient may not have percutaneous endoscopic gastrostomy (PEG) or gastrostomy (G) tube.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated
Primary Objectives:
- (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC).
- (Phase II) To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study.
Secondary Objectives:
- (Phase I and II) To evaluate the pharmacokinetic interaction between the combination.
- (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for further study alone or in combination with cytotoxic chemotherapy.
Read the detailed description
Patients will be treated with oral Tarceva daily for 21 days each cycle. Patients will receive Avastin by IV on day 1 of each 21-day cycle. If a patient has no grade 3 or 4 toxicities after the 1st cycle, then the patient may continue the same doses of Tarceva and Avastin for another cycle. If the patient has response or stable disease after 6 weeks (2 cycles), the patient may continue on the same doses of Tarceva and Avastin. A patient may receive treatment on this study for up to one year, unless his or her disease progresses or side effects become too severe.
The starting dose is 100 mg daily of Tarceva and 7.5 mg/kg every 21 days of Avastin.
- Conditions
- Lung Cancer
- Being tested
- Avastin, Tarceva
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Lung Cancer, Avastin, Bevacizumab, rhuMAb VEGF, Anti-VEGF monoclonal antibody, Tarceva, OSI-774, Erlotinib Hydrocholoride
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
Also called rhuMAb VEGF, Bevacizumab, Anti-VEGF monoclonal antibody
7.5 mg/kg By Vein on Day 1 of Every 21 Day Cycle
TarcevaDrug
Also called OSI-774, Erlotinib Hydrocholoride
100 mg By Mouth Daily for 3 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Avastin + Tarceva | Experimental | Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily. Receives: Drug: Avastin; Drug: Tarceva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin
Measured: After each 21 day cycle
Secondary outcomes (1)
Response in Patients With NSCLC Receiving Combination Avastin and Tarceva
Measured: 6 weeks (2 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2002 (estimated)
- Study start1 Aug 2002
- Primary completion15 May 2006
- Study completion15 May 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Vanderbilt-Ingram Cancer Center
- Responsible party
- Sponsor
- Investigators
- Roy S. Herbst, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043823
- Sponsor's protocol ID
- ID01-604
- Other IDs
- VICC THO 0206
- Status last verified
- Nov 2018
- First submitted
- 14 Aug 2002
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated
- ClinicalTrials.gov ID
- NCT00043823
- Acronym / sponsor ID
- ID01-604
- Conditions
- Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Lung Cancer, Avastin, Bevacizumab, rhuMAb VEGF, Anti-VEGF monoclonal antibody, Tarceva
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc., Vanderbilt-Ingram Cancer Center
- Study start
- 1 Aug 2002 (actual)
- Primary completion
- 15 May 2006 (actual)
- Study completion
- 15 May 2006 (actual)
- First posted
- 15 Aug 2002 (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.
Primary Objectives:
- (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC).
- (Phase II) To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study.
Secondary Objectives:
- (Phase I and II) To evaluate the pharmacokinetic interaction between the combination.
- (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for further study alone or in combination with cytotoxic chemotherapy.
Detailed description
Patients will be treated with oral Tarceva daily for 21 days each cycle. Patients will receive Avastin by IV on day 1 of each 21-day cycle. If a patient has no grade 3 or 4 toxicities after the 1st cycle, then the patient may continue the same doses of Tarceva and Avastin for another cycle. If the patient has response or stable disease after 6 weeks (2 cycles), the patient may continue on the same doses of Tarceva and Avastin. A patient may receive treatment on this study for up to one year, unless his or her disease progresses or side effects become too severe.
The starting dose is 100 mg daily of Tarceva and 7.5 mg/kg every 21 days of Avastin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin + Tarceva | Experimental | Drug: Avastin, Drug: TarcevaCombination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has histologically proven stage IIIB with pleural effusion, stage IV or recurrent non-squamous NSCLC.
- Patient has a Karnofsky performance status >=70%.
- Patient has adequate bone marrow function: WBC >= 3,000 cells/mm3, ANC >= 1,500 cells/mm3, platelet count >= 100,000 cells/mm3, Hgb >= 9.0 g/dL.
- Patient has adequate liver function: total bilirubin level <= 2.0 mg/dL, albumin >= 2.5 g/dL.
- Transaminases (aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT)) and alkaline phosphatase may be up to 2.5 x ULN.
Key exclusion criteria (18 listed)
- Patient has not received prior chemotherapeutic regimens for advanced disease.
- Patient has received prior biologic therapy targeting epidermal growth factor receptor (EGFR) and/or Vascular endothelial growth factor (VEGF).
- Patient has received radiation therapy within the past 3 weeks.
- Patient has signs or symptoms of acute infection requiring systemic therapy.
- Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
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 |
|---|---|---|
| AvastinAlso: rhuMAb VEGF, Bevacizumab, Anti-VEGF monoclonal antibody7.5 mg/kg By Vein on Day 1 of Every 21 Day Cycle | Drug | Avastin + Tarceva |
| TarcevaAlso: OSI-774, Erlotinib Hydrocholoride100 mg By Mouth Daily for 3 Weeks | Drug | Avastin + Tarceva |
Primary outcome
Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin
Time frame: After each 21 day cycle
1 secondary outcome
Response in Patients With NSCLC Receiving Combination Avastin and Tarceva
Time frame: 6 weeks (2 cycles)
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 7 Nov 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Roy S. Herbst, MD, PhD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Avastin and Tarceva in people with Lung Cancer, run by M.D. Anderson Cancer Center at 2 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 8 inclusion and 18 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
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.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin (time frame: After each 21 day cycle). 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 7 Nov 2018.